It has been more than 120 years since Ernst Wertheim, a Viennese surgeon, performed and described what is considered to have been the first radical total hysterectomy with lymphadenectomy for early-stage cervical cancer, yet this morbid procedure remains the standard of care for most early-stage cervical cancers. The rationale for this procedure, which included removal of the parametrial tissue, uterosacral and cardinal ligaments, and upper vagina en bloc with the cervix and uterus, was to obtain margins around a cancer that has a dominant radial growth pattern. The morbidity associated with this procedure is substantial. The parametrium houses important vascular, neural, and urologic structures. Unlike extrafascial hysterectomy, often referred to as “simple” hysterectomy, in which surgeons follow a fascial plane, and therefore a relatively avascular dissection, surgeons performing radical hysterectomy must venture outside of these embryologic fusion planes into less well–defined anatomy. Therefore, surgical complications are relatively common including hemorrhage, ureteral and bladder injury, as well as late-onset devastating complications such as fistula, urinary retention, or incontinence, and sexual dysfunction.¹ More recently, variations of the Wertheim-Meigs radical hysterectomy have been described, and objective classifications created, which include modified radical procedures (removing less parametria) and nerve-sparing procedures to facilitate standardized nomenclature for tailoring the most appropriate procedure for any given tumor.²

Courtesy Dr. Emma Rossi

The trend, and a positive one at that, over the course of the past century, has been a move away from routine radical surgical procedures for most clinical stage 1 cancers. No better example exists than breast cancer, in which the Halsted radical mastectomy has been largely replaced by less morbid breast-conserving or nonradical procedures with adjunct medical and radiation therapies offered to achieve high rates of cure with far more acceptable patient-centered outcomes.³ And so why is it that radical hysterectomy is still considered the standard of care for all but the smallest of microscopic cervical cancers?

The risk of lymph node metastases or recurrence is exceptionally low for women with microscopic (stage IA1) cervical cancers that are less than 3 mm in depth. Therefore, the National Comprehensive Cancer Network guidelines recommend nonradical surgical remedies (such as extrafascial hysterectomy, or cone biopsy or trachelectomy if fertility preservation is desired) for this earlier stage of disease.⁴ If there is lymphovascular space invasion (an indicator of poor prognosis and potential lymphatic involvement), a lymphadenectomy or sentinel lymph node biopsy is also recommended. For women with stage IA2 or IB lesions, radical excisions (either trachelectomy or hysterectomy) are considered the standard of care. However, this “gold standard” was achieved largely through legacy, and not a result of randomized trials comparing its outcomes with nonradical procedures.

Initial strides away from radical cervical cancer surgery focused on the goal of fertility preservation via radical trachelectomy which allowed women to preserve an intact uterine fundus. This was initially met with skepticism and concern that surgeons could be sacrificing oncologic outcomes in order to preserve a woman’s fertility. Thanks to pioneering work, including prospective research studies by surgeon innovators it has been shown that, in appropriately selected candidates with tumors less than 2 cm, it is an accepted standard of care.⁴ Radical vaginal or abdominal trachelectomy is associated with cancer recurrence rates of less than 5% and successful pregnancy in approximately three-quarters of patients in whom this is desired.^5,6 However, full-term pregnancy is achieved in 50%-75% of cases, reflecting increased obstetric risk, and radical trachelectomy still subjects patients to the morbidity of a radical parametrial resection, despite the fact that many of them will have no residual carcinoma in their final pathological specimens.

Therefore, can we be even more conservative in our surgery for these patients? Are simple hysterectomy or conization potentially adequate treatments for small (<2 cm) stage IA2 and IB1 lesions that have favorable histology (<10 mm stromal invasion, low-risk histology, no lymphovascular space involvement, negative margins on conization and no lymph node metastases)? In patients whose tumor exhibits these histologic features, the likelihood of parametrial involvement is approximately 1%, calling into question the virtue of parametrial resection.⁷ Observational studies have identified mixed results on the safety of conservative surgical techniques in early-stage cervical cancer. In a study of the National Cancer Database, the outcomes of 2,543 radical hysterectomies and 1,388 extrafascial hysterectomies for women with stage IB1 disease were evaluated and observed a difference in 5-year survival (92.4% vs. 95.3%) favoring the radical procedure.⁸ Unfortunately, database analyses such as these are limited by potential confounders and discordance between the groups such as rates of lymphadenectomy, known involvement of oncologic surgeon specialists, and margin status. An alternative evaluation of the Surveillance, Epidemiology, and End Results database including 2,571 patients with stage IB1 disease, all of whom had lymphadenectomy performed, showed no difference in 10-year disease-specific survival between the two surgical approaches.⁹

Ultimately, whether conservative procedures (such as conization or extrafascial hysterectomy) can be offered to women with small, low-risk IB1 or IA2 cervical cancers will be best determined by prospective single-arm or randomized trials. Fortunately, these are underway. Preliminary results from the ConCerv trial in which 100 women with early-stage, low-risk stage IA2 and IB1 cervical cancer were treated with either repeat conization or extrafascial hysterectomy with sentinel lymph node biopsy showed acceptably low rates of recurrence (3%) with this approach.¹⁰ If the mature data supports this finding, it seems that, for appropriately selected and well-counseled patients, conservative surgery may become more broadly accepted as a reasonable option for treatment that spares women not only loss of fertility, but also the early and late surgical morbidity from radical procedures.

In the meantime, until more is known about the oncologic safety of nonradical procedures for stage IA2 and IB1 cervical cancer, this option should not be considered standard of care, and only offered to patients with favorable tumor factors who are well counseled regarding the uncertainty of this approach. It is critical that patients with early-stage cervical cancer be evaluated by a gynecologic cancer specialist prior to definitive surgical treatment as they are best equipped to evaluate risk profiles and counsel about her options for surgery, its known and unknown consequences, and the appropriateness of fertility preservation or radicality of surgery. We eagerly await the results of trials evaluating the safety of conservative cervical cancer surgery, which promise to advance us from 19th-century practices, preserving not only fertility, but also quality of life.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no disclosures and can be contacted at [email protected].

References

1. Trimbos JB et al. Eur J Cancer. 2004;40(3):375-8.

2. Querleu D and Morrow CP. Lancet Oncol. 2008;9:297-303.

3. Sakorafas GH and Safioleas M. Eur J Cancer Care. 2010 Mar;19(2):145-66.

4. National Comprehensive Cancer Network. Cervical Cancer (Version 1.2021). https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf. Accessed 2021 Apr 21.

5. Plante M et al. Gynecol Oncol. 2011;121:290-7.

6. Wethington SL et al. Int J Gynecol Cancer. 2012;22:1251-7.

7. Domgue J and Schmeler K. Best Pract Res Clin Obstet Gynaecol. 2019 Feb;55:79-92.

8. Sia TY et al. Obstet Gyenecol. 2019;134(6):1132.

9. Tseng J et al. Gynecol Oncol. 2018;150(1):44.

10. Schmeler K et al. Int J Gynecol Cancer. 2019;29:A14-5.

It has been more than 120 years since Ernst Wertheim, a Viennese surgeon, performed and described what is considered to have been the first radical total hysterectomy with lymphadenectomy for early-stage cervical cancer, yet this morbid procedure remains the standard of care for most early-stage cervical cancers. The rationale for this procedure, which included removal of the parametrial tissue, uterosacral and cardinal ligaments, and upper vagina en bloc with the cervix and uterus, was to obtain margins around a cancer that has a dominant radial growth pattern. The morbidity associated with this procedure is substantial. The parametrium houses important vascular, neural, and urologic structures. Unlike extrafascial hysterectomy, often referred to as “simple” hysterectomy, in which surgeons follow a fascial plane, and therefore a relatively avascular dissection, surgeons performing radical hysterectomy must venture outside of these embryologic fusion planes into less well–defined anatomy. Therefore, surgical complications are relatively common including hemorrhage, ureteral and bladder injury, as well as late-onset devastating complications such as fistula, urinary retention, or incontinence, and sexual dysfunction.¹ More recently, variations of the Wertheim-Meigs radical hysterectomy have been described, and objective classifications created, which include modified radical procedures (removing less parametria) and nerve-sparing procedures to facilitate standardized nomenclature for tailoring the most appropriate procedure for any given tumor.²

Courtesy Dr. Emma Rossi

The trend, and a positive one at that, over the course of the past century, has been a move away from routine radical surgical procedures for most clinical stage 1 cancers. No better example exists than breast cancer, in which the Halsted radical mastectomy has been largely replaced by less morbid breast-conserving or nonradical procedures with adjunct medical and radiation therapies offered to achieve high rates of cure with far more acceptable patient-centered outcomes.³ And so why is it that radical hysterectomy is still considered the standard of care for all but the smallest of microscopic cervical cancers?

The risk of lymph node metastases or recurrence is exceptionally low for women with microscopic (stage IA1) cervical cancers that are less than 3 mm in depth. Therefore, the National Comprehensive Cancer Network guidelines recommend nonradical surgical remedies (such as extrafascial hysterectomy, or cone biopsy or trachelectomy if fertility preservation is desired) for this earlier stage of disease.⁴ If there is lymphovascular space invasion (an indicator of poor prognosis and potential lymphatic involvement), a lymphadenectomy or sentinel lymph node biopsy is also recommended. For women with stage IA2 or IB lesions, radical excisions (either trachelectomy or hysterectomy) are considered the standard of care. However, this “gold standard” was achieved largely through legacy, and not a result of randomized trials comparing its outcomes with nonradical procedures.

Initial strides away from radical cervical cancer surgery focused on the goal of fertility preservation via radical trachelectomy which allowed women to preserve an intact uterine fundus. This was initially met with skepticism and concern that surgeons could be sacrificing oncologic outcomes in order to preserve a woman’s fertility. Thanks to pioneering work, including prospective research studies by surgeon innovators it has been shown that, in appropriately selected candidates with tumors less than 2 cm, it is an accepted standard of care.⁴ Radical vaginal or abdominal trachelectomy is associated with cancer recurrence rates of less than 5% and successful pregnancy in approximately three-quarters of patients in whom this is desired.^5,6 However, full-term pregnancy is achieved in 50%-75% of cases, reflecting increased obstetric risk, and radical trachelectomy still subjects patients to the morbidity of a radical parametrial resection, despite the fact that many of them will have no residual carcinoma in their final pathological specimens.

Therefore, can we be even more conservative in our surgery for these patients? Are simple hysterectomy or conization potentially adequate treatments for small (<2 cm) stage IA2 and IB1 lesions that have favorable histology (<10 mm stromal invasion, low-risk histology, no lymphovascular space involvement, negative margins on conization and no lymph node metastases)? In patients whose tumor exhibits these histologic features, the likelihood of parametrial involvement is approximately 1%, calling into question the virtue of parametrial resection.⁷ Observational studies have identified mixed results on the safety of conservative surgical techniques in early-stage cervical cancer. In a study of the National Cancer Database, the outcomes of 2,543 radical hysterectomies and 1,388 extrafascial hysterectomies for women with stage IB1 disease were evaluated and observed a difference in 5-year survival (92.4% vs. 95.3%) favoring the radical procedure.⁸ Unfortunately, database analyses such as these are limited by potential confounders and discordance between the groups such as rates of lymphadenectomy, known involvement of oncologic surgeon specialists, and margin status. An alternative evaluation of the Surveillance, Epidemiology, and End Results database including 2,571 patients with stage IB1 disease, all of whom had lymphadenectomy performed, showed no difference in 10-year disease-specific survival between the two surgical approaches.⁹

Ultimately, whether conservative procedures (such as conization or extrafascial hysterectomy) can be offered to women with small, low-risk IB1 or IA2 cervical cancers will be best determined by prospective single-arm or randomized trials. Fortunately, these are underway. Preliminary results from the ConCerv trial in which 100 women with early-stage, low-risk stage IA2 and IB1 cervical cancer were treated with either repeat conization or extrafascial hysterectomy with sentinel lymph node biopsy showed acceptably low rates of recurrence (3%) with this approach.¹⁰ If the mature data supports this finding, it seems that, for appropriately selected and well-counseled patients, conservative surgery may become more broadly accepted as a reasonable option for treatment that spares women not only loss of fertility, but also the early and late surgical morbidity from radical procedures.

In the meantime, until more is known about the oncologic safety of nonradical procedures for stage IA2 and IB1 cervical cancer, this option should not be considered standard of care, and only offered to patients with favorable tumor factors who are well counseled regarding the uncertainty of this approach. It is critical that patients with early-stage cervical cancer be evaluated by a gynecologic cancer specialist prior to definitive surgical treatment as they are best equipped to evaluate risk profiles and counsel about her options for surgery, its known and unknown consequences, and the appropriateness of fertility preservation or radicality of surgery. We eagerly await the results of trials evaluating the safety of conservative cervical cancer surgery, which promise to advance us from 19th-century practices, preserving not only fertility, but also quality of life.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no disclosures and can be contacted at [email protected].

References

1. Trimbos JB et al. Eur J Cancer. 2004;40(3):375-8.

2. Querleu D and Morrow CP. Lancet Oncol. 2008;9:297-303.

3. Sakorafas GH and Safioleas M. Eur J Cancer Care. 2010 Mar;19(2):145-66.

4. National Comprehensive Cancer Network. Cervical Cancer (Version 1.2021). https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf. Accessed 2021 Apr 21.

5. Plante M et al. Gynecol Oncol. 2011;121:290-7.

6. Wethington SL et al. Int J Gynecol Cancer. 2012;22:1251-7.

7. Domgue J and Schmeler K. Best Pract Res Clin Obstet Gynaecol. 2019 Feb;55:79-92.

8. Sia TY et al. Obstet Gyenecol. 2019;134(6):1132.

9. Tseng J et al. Gynecol Oncol. 2018;150(1):44.

10. Schmeler K et al. Int J Gynecol Cancer. 2019;29:A14-5.

It has been more than 120 years since Ernst Wertheim, a Viennese surgeon, performed and described what is considered to have been the first radical total hysterectomy with lymphadenectomy for early-stage cervical cancer, yet this morbid procedure remains the standard of care for most early-stage cervical cancers. The rationale for this procedure, which included removal of the parametrial tissue, uterosacral and cardinal ligaments, and upper vagina en bloc with the cervix and uterus, was to obtain margins around a cancer that has a dominant radial growth pattern. The morbidity associated with this procedure is substantial. The parametrium houses important vascular, neural, and urologic structures. Unlike extrafascial hysterectomy, often referred to as “simple” hysterectomy, in which surgeons follow a fascial plane, and therefore a relatively avascular dissection, surgeons performing radical hysterectomy must venture outside of these embryologic fusion planes into less well–defined anatomy. Therefore, surgical complications are relatively common including hemorrhage, ureteral and bladder injury, as well as late-onset devastating complications such as fistula, urinary retention, or incontinence, and sexual dysfunction.¹ More recently, variations of the Wertheim-Meigs radical hysterectomy have been described, and objective classifications created, which include modified radical procedures (removing less parametria) and nerve-sparing procedures to facilitate standardized nomenclature for tailoring the most appropriate procedure for any given tumor.²

Courtesy Dr. Emma Rossi

The trend, and a positive one at that, over the course of the past century, has been a move away from routine radical surgical procedures for most clinical stage 1 cancers. No better example exists than breast cancer, in which the Halsted radical mastectomy has been largely replaced by less morbid breast-conserving or nonradical procedures with adjunct medical and radiation therapies offered to achieve high rates of cure with far more acceptable patient-centered outcomes.³ And so why is it that radical hysterectomy is still considered the standard of care for all but the smallest of microscopic cervical cancers?

The risk of lymph node metastases or recurrence is exceptionally low for women with microscopic (stage IA1) cervical cancers that are less than 3 mm in depth. Therefore, the National Comprehensive Cancer Network guidelines recommend nonradical surgical remedies (such as extrafascial hysterectomy, or cone biopsy or trachelectomy if fertility preservation is desired) for this earlier stage of disease.⁴ If there is lymphovascular space invasion (an indicator of poor prognosis and potential lymphatic involvement), a lymphadenectomy or sentinel lymph node biopsy is also recommended. For women with stage IA2 or IB lesions, radical excisions (either trachelectomy or hysterectomy) are considered the standard of care. However, this “gold standard” was achieved largely through legacy, and not a result of randomized trials comparing its outcomes with nonradical procedures.

Initial strides away from radical cervical cancer surgery focused on the goal of fertility preservation via radical trachelectomy which allowed women to preserve an intact uterine fundus. This was initially met with skepticism and concern that surgeons could be sacrificing oncologic outcomes in order to preserve a woman’s fertility. Thanks to pioneering work, including prospective research studies by surgeon innovators it has been shown that, in appropriately selected candidates with tumors less than 2 cm, it is an accepted standard of care.⁴ Radical vaginal or abdominal trachelectomy is associated with cancer recurrence rates of less than 5% and successful pregnancy in approximately three-quarters of patients in whom this is desired.^5,6 However, full-term pregnancy is achieved in 50%-75% of cases, reflecting increased obstetric risk, and radical trachelectomy still subjects patients to the morbidity of a radical parametrial resection, despite the fact that many of them will have no residual carcinoma in their final pathological specimens.

Therefore, can we be even more conservative in our surgery for these patients? Are simple hysterectomy or conization potentially adequate treatments for small (<2 cm) stage IA2 and IB1 lesions that have favorable histology (<10 mm stromal invasion, low-risk histology, no lymphovascular space involvement, negative margins on conization and no lymph node metastases)? In patients whose tumor exhibits these histologic features, the likelihood of parametrial involvement is approximately 1%, calling into question the virtue of parametrial resection.⁷ Observational studies have identified mixed results on the safety of conservative surgical techniques in early-stage cervical cancer. In a study of the National Cancer Database, the outcomes of 2,543 radical hysterectomies and 1,388 extrafascial hysterectomies for women with stage IB1 disease were evaluated and observed a difference in 5-year survival (92.4% vs. 95.3%) favoring the radical procedure.⁸ Unfortunately, database analyses such as these are limited by potential confounders and discordance between the groups such as rates of lymphadenectomy, known involvement of oncologic surgeon specialists, and margin status. An alternative evaluation of the Surveillance, Epidemiology, and End Results database including 2,571 patients with stage IB1 disease, all of whom had lymphadenectomy performed, showed no difference in 10-year disease-specific survival between the two surgical approaches.⁹

Ultimately, whether conservative procedures (such as conization or extrafascial hysterectomy) can be offered to women with small, low-risk IB1 or IA2 cervical cancers will be best determined by prospective single-arm or randomized trials. Fortunately, these are underway. Preliminary results from the ConCerv trial in which 100 women with early-stage, low-risk stage IA2 and IB1 cervical cancer were treated with either repeat conization or extrafascial hysterectomy with sentinel lymph node biopsy showed acceptably low rates of recurrence (3%) with this approach.¹⁰ If the mature data supports this finding, it seems that, for appropriately selected and well-counseled patients, conservative surgery may become more broadly accepted as a reasonable option for treatment that spares women not only loss of fertility, but also the early and late surgical morbidity from radical procedures.

In the meantime, until more is known about the oncologic safety of nonradical procedures for stage IA2 and IB1 cervical cancer, this option should not be considered standard of care, and only offered to patients with favorable tumor factors who are well counseled regarding the uncertainty of this approach. It is critical that patients with early-stage cervical cancer be evaluated by a gynecologic cancer specialist prior to definitive surgical treatment as they are best equipped to evaluate risk profiles and counsel about her options for surgery, its known and unknown consequences, and the appropriateness of fertility preservation or radicality of surgery. We eagerly await the results of trials evaluating the safety of conservative cervical cancer surgery, which promise to advance us from 19th-century practices, preserving not only fertility, but also quality of life.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no disclosures and can be contacted at [email protected].

References

1. Trimbos JB et al. Eur J Cancer. 2004;40(3):375-8.

2. Querleu D and Morrow CP. Lancet Oncol. 2008;9:297-303.

3. Sakorafas GH and Safioleas M. Eur J Cancer Care. 2010 Mar;19(2):145-66.

4. National Comprehensive Cancer Network. Cervical Cancer (Version 1.2021). https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf. Accessed 2021 Apr 21.

5. Plante M et al. Gynecol Oncol. 2011;121:290-7.

6. Wethington SL et al. Int J Gynecol Cancer. 2012;22:1251-7.

7. Domgue J and Schmeler K. Best Pract Res Clin Obstet Gynaecol. 2019 Feb;55:79-92.

8. Sia TY et al. Obstet Gyenecol. 2019;134(6):1132.

9. Tseng J et al. Gynecol Oncol. 2018;150(1):44.

10. Schmeler K et al. Int J Gynecol Cancer. 2019;29:A14-5.

Dear colleagues and friends,

The Perspectives series returns, this time with an exciting discussion about antibiotic use in acute uncomplicated diverticulitis. It has been fascinating to witness this field evolve from an era where not using antibiotics was inconceivable! Dr. Anne F. Peery and Dr. Neil Stollman, both recognized experts in the matter, provide arguments to both sides of the debate, as well as much-needed nuance. As always, I welcome your comments and suggestions for future topics at [email protected]. Thank you for your support, and I hope you will enjoy the reading and learning from this as much as I did.

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.

Think carefully about when to withhold

For decades, it was standard practice to give antibiotics to all patients with acute uncomplicated diverticulitis (AUD). While most patients with a first diagnosis of AUD recover within a few weeks, a small proportion will develop a complication.¹ Among generally healthy patients with an initial diagnosis of AUD, about 3% will progress to complicated diverticulitis, and about 1% will require emergency surgery within 6 months. Around another 6% of cases will develop chronic diverticulitis with ongoing diverticular inflammation that persists for weeks to months.

Because the complications are uncommon, we don’t know if antibiotics reduce the risk of progression to complicated diverticulitis, emergency surgery, or the development of chronic diverticulitis. Investigating these patient-centered and morbid outcomes would require trials enrolling thousands of patients and to following these patients for months. This trial hasn’t happened yet.

To date, only small studies have compared the use of antibiotics with no antibiotics in patients with AUD. A review sponsored by the Agency for Healthcare Research and Quality published last year concluded that the current evidence was too sparse or too inconsistent to make strong conclusions about the use of antibiotics for patients with uncomplicated diverticulitis.²

With little evidence for or against antibiotics, recent guidelines have begun to recommend that antibiotics be used selectively, rather than routinely, in patients with diverticulitis.³ “Selectively” clearly means that there are some patients who should receive antibiotics, but the guidelines are vague about who those patients are. To this end, it is safest to refer to those small, underpowered trials to identify which patients are at the greatest risk of developing a complication.^1,4 The authors of those trials considered a number of groups high risk and therefore excluded them from those trials. In the absence of further definitive research, it seems clear that those groups, listed below, should therefore be selected for antibiotic treatment:

• Patients with complicated diverticulitis including paracolic extraluminal air on CT scan.
• Patients who are immunocompromised.
• Patients with a high fever, affected general condition, or clinical suspicion of sepsis.
• Patients with inflammatory bowel disease.
• Patients who are pregnant or breast feeding.

As with most clinical trials, participants in these smaller trials were younger (median age, late 50s) and healthier (63% normal, healthy patient; 34% mild systemic disease; 4% severe systemic disease) than the general population. In secondary analyses, however, several factors were independently associated with a complicated disease course after an initial diagnosis of acute uncomplicated diverticulitis. As with the first list above, the following high-risk patients should also be treated with antibiotics at diagnosis:

• Patients with American Society of Anesthesiologists scores III or IV were 4.4 times more likely to have a poor outcome, compared with those with ASA score I.
• Patients with ASA score II were 2.0 times more likely to have a poor outcome, compared with ASA score I.
• Patients with symptoms for more than 5 days at diagnosis were 3.3 times more likely to have a poor outcome, compared with those with symptoms for 5 days or less.
• Patients with vomiting at diagnosis were 3.9 times more likely to have a poor outcome, compared with those who were not vomiting.
• Patients with C-reactive protein levels higher than 140 mg/L at diagnosis were 2.9 times more likely to have a poor outcome, compared with C-reactive protein level of 140 mg/L or less.
• Patients with white blood cell count greater than 15 x 10⁹ cells/L at diagnosis were 3.7 times more likely to have a poor outcome, compared with those with 15 x 10⁹ cells/L.
• Patients with a longer segment (>86mm) of inflamed colon on CT scan were more likely to have a poor outcome, compared those who had a shorter segment (<65mm).

To help clinicians think about antibiotic treatment in patients with AUD, a recent American Gastroenterological Association clinical practice update provided the following advice: First, antibiotic treatment is advised in patients with uncomplicated diverticulitis who have comorbidities or are frail, who present with refractory symptoms or vomiting, or who have a C-reactive protein level greater than 140 mg/L, or baseline white blood cell count greater than 15 x 10⁹ cells/L.⁵ Also, antibiotic treatment is advised in patients with complicated diverticulitis or uncomplicated diverticulitis with a fluid collection or longer segment of inflammation on CT scan. Finally, patients with uncomplicated diverticulitis who are immunosuppressed are high risk for progression to complicated diverticulitis or sepsis and should be treated with antibiotics.

The lists above clearly leave some patients with AUD who may be managed without antibiotics. These patients are otherwise healthy, have good social support, access to health care, and are experiencing a mild, self-limited episode. Avoiding antibiotics requires shared decision-making with a well-informed patient. I have patients who have embraced this approach, while others found this unacceptable. Given the current level of uncertainty in the literature, I make it my practice to offer antibiotics to any patient who feels strongly about receiving them.

As with many issues in modern medicine, the use of antibiotics in AUD is an unsettled question. Given the known harms of progression of diverticulitis, it is clearly safest to treat patients who were excluded from the small studies we have or flagged by those same studies as being at increased risk of progression. Our uncertainty also demands a shared decision-making model, filling in our patients on what we can and cannot say with confidence. As is often the case, further research is desperately needed. Until that happens, antibiotics for AUD will remain a regular part of my practice.

Anne F. Peery, MD, MSCR, is with the center for gastrointestinal biology and disease at the University of North Carolina at Chapel Hill. She has no conflicts to disclose.

References

1. Daniels L et al. Br J Surg. 2017 Jan;104(1):52-61.

2. Balk EM et al. Management of Colonic Diverticulitis. Comparative Effectiveness Review No. 233. Agency for Healthcare Research and Quality. 2020 Oct. doi: 10.23970/AHRQEPCCER233.

3. Stollman N et al. Gastroenterology. 2015 Dec;149(7):1944-9.

4. Chabok A et al. Br J Surg. 2012 Jan 30;99(4):532-9.

5. Peery AF et al. Gastroenterology. 2021 Feb;160(3):906-11.e1.

The data are robust for withholding more often

That we are engaged in a legitimate debate about the role of antibiotics in acute uncomplicated diverticulitis (AUD) is itself quite notable. In the 1999 American College of Gastroenterology Practice Guidelines,¹ we did not even entertain the concept of withholding antibiotics; the only discussion points were intravenous versus oral. Fast forward 15 years, and in the 2015 American Gastroenterological Association practice guidelines (which the other contributor for this installment of Perspectives, Anne F. Peery, MD, and I worked on together) our first recommendation was that antibiotics should be used “selectively,” rather than routinely.² This did generate some raised eyebrows and hand-wringing in the community, but our position was the result of a rigorous data analysis process and we stood by it.

In fact, Dr. Peery and I also coauthored an accompanying editorial that concluded with an important endorsement “allowing the clinician to consider withholding antibiotics from select uncomplicated patients with mild disease.” I suspect, then, that Dr. Peery and I are very much coincident in our overall thoughts here, and I’m pretty sure that neither of us would defend an “always” or “never” stance on this issue, so for this educational debate, we’re really talking about where in the middle to draw the line (that is, how to define “selectively”). To that end, I will defend the supposition that the subsequent data in support of withholding antibiotics remains robust and even more supportive of this practice in many (but certainly not all) patients with acute, uncomplicated diverticulitis.

The logic underlying selective use was based on two drivers over the past decade, one being an emerging concept that diverticular pathology was often inflammatory rather than solely infectious, coupled with a timely and very important worldwide push toward restraint of antibiotic use. A recent retrospective claims analysis of outpatient antibiotic use for immunocompetent patients with AUD did reported that the dominant antibiotic combination used, metronidazole plus a fluoroquinolone, was associated with an increased risk of Clostridioides difficile infection, compared with the far less frequently used amoxicillin/clavulanate regimen, which highlights that routine antibiotics are not without risk.³

Recently, the U.S. Agency for Healthcare Research and Quality performed a rigorous meta-analysis of this body of evidence, and summarized that “antibiotic treatment may not affect pain symptoms, length of hospital stay, recurrence risk, quality of life, or need for surgery, compared to no antibiotic treatment,” with an admitted low strength of evidence (based on four randomized, controlled trials).⁴

Finally, I’ll close my evidence-based case with a quote from a Clinical Practice Update just published in February 2021 in Gastroenterology: “Antibiotic treatment can be used selectively, rather than routinely, in immunocompetent patients with mild uncomplicated diverticulitis. ... Antibiotic treatment is advised in patients with uncomplicated diverticulitis who have comorbidities or are frail, who present with refractory symptoms or vomiting, or who have a [C-reactive protein] >140 mg/L or baseline [white blood cell count] > 15 x 10⁹. Antibiotic treatment is advised in patients with complicated diverticulitis or uncomplicated diverticulitis with a fluid collection or longer segment of inflammation on CT scan.”⁵ I think this is most excellent advice, providing a practical and clinically useful framework for those in whom antibiotics absolutely should be used, but permitting a fairly large group to avoid antibiotics, which may carry significant harm, based on strong consistent data that does not support a benefit.

So, practically speaking, things are a bit harder for us now when our patient shows up in the ED and if found to have AUD on CT. In the “old days” (that is, the early 2000s), a patient with either clinically suspected or CT-confirmed AUD was simply given antibiotics, mostly a fluoroquinolone, and this was community standard. The only real decision tree was inpatient or outpatient. But now, I would respectfully suggest, we need to invest a bit more time on a nuanced discussion with the potential “no antibiotics” patient (for example, one without immunosuppression, severe comorbidities, or lab or imaging markers of aggressive disease). It is now appropriate to inform such a patient that the data suggest that a conservative approach will not increase their risk of complications and may well spare them antibiotic-related morbidity.

In the context of that informed discussion, factually framed by the practitioner, many patients should (and will, in my experience, although the San Francisco Bay Area may not entirely reflect the country as a whole) choose a strategy of observation. Of course, close follow-up with such patients is required, as is clear reassurance that if things “turn bad” that we’re available and antibiotics remain a salvage option. The “write a script and be done” days are over, and while withholding antibiotics may still feel dangerous or uncomfortable to the patient (or to us), the data is the data, and our patients deserve to at least be offered that option.

Neil Stollman, MD, AGAF, FACG, is chairman of the division of gastroenterology at Alta Bates Summit Medical Center in Oakland, Calif., and an associate clinical professor of medicine in the division of gastroenterology at the University of California, San Francisco. He discloses being a consultant for Cosmo Pharmaceuticals, which has a potential future diverticulitis study of a rifampin-class antibiotic.

References

1. Stollman N and Raskin JB. Am J Gastroenterol. 1999 Nov;94(11):3110-21.

2. Peery AF and Stollman N. Gastroenterology. 2015 Dec;149(7):1944-9.

3. Gaber CE et al. Ann Intern Med. 2021 Feb 23. doi: 10.7326/M20-6315.

4. Balk EM et al. Management of Colonic Diverticulitis. Comparative Effectiveness Review No. 233. Agency for Healthcare Research and Quality. October 2020. doi: 10.23970/AHRQEPCCER233.

5. Peery AF et al. Gastroenterology. 2021 Feb;160(3):906-11.e1.

Dear colleagues and friends,

The Perspectives series returns, this time with an exciting discussion about antibiotic use in acute uncomplicated diverticulitis. It has been fascinating to witness this field evolve from an era where not using antibiotics was inconceivable! Dr. Anne F. Peery and Dr. Neil Stollman, both recognized experts in the matter, provide arguments to both sides of the debate, as well as much-needed nuance. As always, I welcome your comments and suggestions for future topics at [email protected]. Thank you for your support, and I hope you will enjoy the reading and learning from this as much as I did.

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.

Think carefully about when to withhold

For decades, it was standard practice to give antibiotics to all patients with acute uncomplicated diverticulitis (AUD). While most patients with a first diagnosis of AUD recover within a few weeks, a small proportion will develop a complication.¹ Among generally healthy patients with an initial diagnosis of AUD, about 3% will progress to complicated diverticulitis, and about 1% will require emergency surgery within 6 months. Around another 6% of cases will develop chronic diverticulitis with ongoing diverticular inflammation that persists for weeks to months.

Because the complications are uncommon, we don’t know if antibiotics reduce the risk of progression to complicated diverticulitis, emergency surgery, or the development of chronic diverticulitis. Investigating these patient-centered and morbid outcomes would require trials enrolling thousands of patients and to following these patients for months. This trial hasn’t happened yet.

To date, only small studies have compared the use of antibiotics with no antibiotics in patients with AUD. A review sponsored by the Agency for Healthcare Research and Quality published last year concluded that the current evidence was too sparse or too inconsistent to make strong conclusions about the use of antibiotics for patients with uncomplicated diverticulitis.²

With little evidence for or against antibiotics, recent guidelines have begun to recommend that antibiotics be used selectively, rather than routinely, in patients with diverticulitis.³ “Selectively” clearly means that there are some patients who should receive antibiotics, but the guidelines are vague about who those patients are. To this end, it is safest to refer to those small, underpowered trials to identify which patients are at the greatest risk of developing a complication.^1,4 The authors of those trials considered a number of groups high risk and therefore excluded them from those trials. In the absence of further definitive research, it seems clear that those groups, listed below, should therefore be selected for antibiotic treatment:

• Patients with complicated diverticulitis including paracolic extraluminal air on CT scan.
• Patients who are immunocompromised.
• Patients with a high fever, affected general condition, or clinical suspicion of sepsis.
• Patients with inflammatory bowel disease.
• Patients who are pregnant or breast feeding.

As with most clinical trials, participants in these smaller trials were younger (median age, late 50s) and healthier (63% normal, healthy patient; 34% mild systemic disease; 4% severe systemic disease) than the general population. In secondary analyses, however, several factors were independently associated with a complicated disease course after an initial diagnosis of acute uncomplicated diverticulitis. As with the first list above, the following high-risk patients should also be treated with antibiotics at diagnosis:

• Patients with American Society of Anesthesiologists scores III or IV were 4.4 times more likely to have a poor outcome, compared with those with ASA score I.
• Patients with ASA score II were 2.0 times more likely to have a poor outcome, compared with ASA score I.
• Patients with symptoms for more than 5 days at diagnosis were 3.3 times more likely to have a poor outcome, compared with those with symptoms for 5 days or less.
• Patients with vomiting at diagnosis were 3.9 times more likely to have a poor outcome, compared with those who were not vomiting.
• Patients with C-reactive protein levels higher than 140 mg/L at diagnosis were 2.9 times more likely to have a poor outcome, compared with C-reactive protein level of 140 mg/L or less.
• Patients with white blood cell count greater than 15 x 10⁹ cells/L at diagnosis were 3.7 times more likely to have a poor outcome, compared with those with 15 x 10⁹ cells/L.
• Patients with a longer segment (>86mm) of inflamed colon on CT scan were more likely to have a poor outcome, compared those who had a shorter segment (<65mm).

To help clinicians think about antibiotic treatment in patients with AUD, a recent American Gastroenterological Association clinical practice update provided the following advice: First, antibiotic treatment is advised in patients with uncomplicated diverticulitis who have comorbidities or are frail, who present with refractory symptoms or vomiting, or who have a C-reactive protein level greater than 140 mg/L, or baseline white blood cell count greater than 15 x 10⁹ cells/L.⁵ Also, antibiotic treatment is advised in patients with complicated diverticulitis or uncomplicated diverticulitis with a fluid collection or longer segment of inflammation on CT scan. Finally, patients with uncomplicated diverticulitis who are immunosuppressed are high risk for progression to complicated diverticulitis or sepsis and should be treated with antibiotics.

The lists above clearly leave some patients with AUD who may be managed without antibiotics. These patients are otherwise healthy, have good social support, access to health care, and are experiencing a mild, self-limited episode. Avoiding antibiotics requires shared decision-making with a well-informed patient. I have patients who have embraced this approach, while others found this unacceptable. Given the current level of uncertainty in the literature, I make it my practice to offer antibiotics to any patient who feels strongly about receiving them.

As with many issues in modern medicine, the use of antibiotics in AUD is an unsettled question. Given the known harms of progression of diverticulitis, it is clearly safest to treat patients who were excluded from the small studies we have or flagged by those same studies as being at increased risk of progression. Our uncertainty also demands a shared decision-making model, filling in our patients on what we can and cannot say with confidence. As is often the case, further research is desperately needed. Until that happens, antibiotics for AUD will remain a regular part of my practice.

Anne F. Peery, MD, MSCR, is with the center for gastrointestinal biology and disease at the University of North Carolina at Chapel Hill. She has no conflicts to disclose.

References

1. Daniels L et al. Br J Surg. 2017 Jan;104(1):52-61.

2. Balk EM et al. Management of Colonic Diverticulitis. Comparative Effectiveness Review No. 233. Agency for Healthcare Research and Quality. 2020 Oct. doi: 10.23970/AHRQEPCCER233.

3. Stollman N et al. Gastroenterology. 2015 Dec;149(7):1944-9.

4. Chabok A et al. Br J Surg. 2012 Jan 30;99(4):532-9.

5. Peery AF et al. Gastroenterology. 2021 Feb;160(3):906-11.e1.

The data are robust for withholding more often

That we are engaged in a legitimate debate about the role of antibiotics in acute uncomplicated diverticulitis (AUD) is itself quite notable. In the 1999 American College of Gastroenterology Practice Guidelines,¹ we did not even entertain the concept of withholding antibiotics; the only discussion points were intravenous versus oral. Fast forward 15 years, and in the 2015 American Gastroenterological Association practice guidelines (which the other contributor for this installment of Perspectives, Anne F. Peery, MD, and I worked on together) our first recommendation was that antibiotics should be used “selectively,” rather than routinely.² This did generate some raised eyebrows and hand-wringing in the community, but our position was the result of a rigorous data analysis process and we stood by it.

In fact, Dr. Peery and I also coauthored an accompanying editorial that concluded with an important endorsement “allowing the clinician to consider withholding antibiotics from select uncomplicated patients with mild disease.” I suspect, then, that Dr. Peery and I are very much coincident in our overall thoughts here, and I’m pretty sure that neither of us would defend an “always” or “never” stance on this issue, so for this educational debate, we’re really talking about where in the middle to draw the line (that is, how to define “selectively”). To that end, I will defend the supposition that the subsequent data in support of withholding antibiotics remains robust and even more supportive of this practice in many (but certainly not all) patients with acute, uncomplicated diverticulitis.

The logic underlying selective use was based on two drivers over the past decade, one being an emerging concept that diverticular pathology was often inflammatory rather than solely infectious, coupled with a timely and very important worldwide push toward restraint of antibiotic use. A recent retrospective claims analysis of outpatient antibiotic use for immunocompetent patients with AUD did reported that the dominant antibiotic combination used, metronidazole plus a fluoroquinolone, was associated with an increased risk of Clostridioides difficile infection, compared with the far less frequently used amoxicillin/clavulanate regimen, which highlights that routine antibiotics are not without risk.³

Recently, the U.S. Agency for Healthcare Research and Quality performed a rigorous meta-analysis of this body of evidence, and summarized that “antibiotic treatment may not affect pain symptoms, length of hospital stay, recurrence risk, quality of life, or need for surgery, compared to no antibiotic treatment,” with an admitted low strength of evidence (based on four randomized, controlled trials).⁴

Finally, I’ll close my evidence-based case with a quote from a Clinical Practice Update just published in February 2021 in Gastroenterology: “Antibiotic treatment can be used selectively, rather than routinely, in immunocompetent patients with mild uncomplicated diverticulitis. ... Antibiotic treatment is advised in patients with uncomplicated diverticulitis who have comorbidities or are frail, who present with refractory symptoms or vomiting, or who have a [C-reactive protein] >140 mg/L or baseline [white blood cell count] > 15 x 10⁹. Antibiotic treatment is advised in patients with complicated diverticulitis or uncomplicated diverticulitis with a fluid collection or longer segment of inflammation on CT scan.”⁵ I think this is most excellent advice, providing a practical and clinically useful framework for those in whom antibiotics absolutely should be used, but permitting a fairly large group to avoid antibiotics, which may carry significant harm, based on strong consistent data that does not support a benefit.

So, practically speaking, things are a bit harder for us now when our patient shows up in the ED and if found to have AUD on CT. In the “old days” (that is, the early 2000s), a patient with either clinically suspected or CT-confirmed AUD was simply given antibiotics, mostly a fluoroquinolone, and this was community standard. The only real decision tree was inpatient or outpatient. But now, I would respectfully suggest, we need to invest a bit more time on a nuanced discussion with the potential “no antibiotics” patient (for example, one without immunosuppression, severe comorbidities, or lab or imaging markers of aggressive disease). It is now appropriate to inform such a patient that the data suggest that a conservative approach will not increase their risk of complications and may well spare them antibiotic-related morbidity.

In the context of that informed discussion, factually framed by the practitioner, many patients should (and will, in my experience, although the San Francisco Bay Area may not entirely reflect the country as a whole) choose a strategy of observation. Of course, close follow-up with such patients is required, as is clear reassurance that if things “turn bad” that we’re available and antibiotics remain a salvage option. The “write a script and be done” days are over, and while withholding antibiotics may still feel dangerous or uncomfortable to the patient (or to us), the data is the data, and our patients deserve to at least be offered that option.

Neil Stollman, MD, AGAF, FACG, is chairman of the division of gastroenterology at Alta Bates Summit Medical Center in Oakland, Calif., and an associate clinical professor of medicine in the division of gastroenterology at the University of California, San Francisco. He discloses being a consultant for Cosmo Pharmaceuticals, which has a potential future diverticulitis study of a rifampin-class antibiotic.

References

1. Stollman N and Raskin JB. Am J Gastroenterol. 1999 Nov;94(11):3110-21.

2. Peery AF and Stollman N. Gastroenterology. 2015 Dec;149(7):1944-9.

3. Gaber CE et al. Ann Intern Med. 2021 Feb 23. doi: 10.7326/M20-6315.

4. Balk EM et al. Management of Colonic Diverticulitis. Comparative Effectiveness Review No. 233. Agency for Healthcare Research and Quality. October 2020. doi: 10.23970/AHRQEPCCER233.

5. Peery AF et al. Gastroenterology. 2021 Feb;160(3):906-11.e1.

Dear colleagues and friends,

The Perspectives series returns, this time with an exciting discussion about antibiotic use in acute uncomplicated diverticulitis. It has been fascinating to witness this field evolve from an era where not using antibiotics was inconceivable! Dr. Anne F. Peery and Dr. Neil Stollman, both recognized experts in the matter, provide arguments to both sides of the debate, as well as much-needed nuance. As always, I welcome your comments and suggestions for future topics at [email protected]. Thank you for your support, and I hope you will enjoy the reading and learning from this as much as I did.

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.

Think carefully about when to withhold

For decades, it was standard practice to give antibiotics to all patients with acute uncomplicated diverticulitis (AUD). While most patients with a first diagnosis of AUD recover within a few weeks, a small proportion will develop a complication.¹ Among generally healthy patients with an initial diagnosis of AUD, about 3% will progress to complicated diverticulitis, and about 1% will require emergency surgery within 6 months. Around another 6% of cases will develop chronic diverticulitis with ongoing diverticular inflammation that persists for weeks to months.

Because the complications are uncommon, we don’t know if antibiotics reduce the risk of progression to complicated diverticulitis, emergency surgery, or the development of chronic diverticulitis. Investigating these patient-centered and morbid outcomes would require trials enrolling thousands of patients and to following these patients for months. This trial hasn’t happened yet.

To date, only small studies have compared the use of antibiotics with no antibiotics in patients with AUD. A review sponsored by the Agency for Healthcare Research and Quality published last year concluded that the current evidence was too sparse or too inconsistent to make strong conclusions about the use of antibiotics for patients with uncomplicated diverticulitis.²

With little evidence for or against antibiotics, recent guidelines have begun to recommend that antibiotics be used selectively, rather than routinely, in patients with diverticulitis.³ “Selectively” clearly means that there are some patients who should receive antibiotics, but the guidelines are vague about who those patients are. To this end, it is safest to refer to those small, underpowered trials to identify which patients are at the greatest risk of developing a complication.^1,4 The authors of those trials considered a number of groups high risk and therefore excluded them from those trials. In the absence of further definitive research, it seems clear that those groups, listed below, should therefore be selected for antibiotic treatment:

• Patients with complicated diverticulitis including paracolic extraluminal air on CT scan.
• Patients who are immunocompromised.
• Patients with a high fever, affected general condition, or clinical suspicion of sepsis.
• Patients with inflammatory bowel disease.
• Patients who are pregnant or breast feeding.

As with most clinical trials, participants in these smaller trials were younger (median age, late 50s) and healthier (63% normal, healthy patient; 34% mild systemic disease; 4% severe systemic disease) than the general population. In secondary analyses, however, several factors were independently associated with a complicated disease course after an initial diagnosis of acute uncomplicated diverticulitis. As with the first list above, the following high-risk patients should also be treated with antibiotics at diagnosis:

• Patients with American Society of Anesthesiologists scores III or IV were 4.4 times more likely to have a poor outcome, compared with those with ASA score I.
• Patients with ASA score II were 2.0 times more likely to have a poor outcome, compared with ASA score I.
• Patients with symptoms for more than 5 days at diagnosis were 3.3 times more likely to have a poor outcome, compared with those with symptoms for 5 days or less.
• Patients with vomiting at diagnosis were 3.9 times more likely to have a poor outcome, compared with those who were not vomiting.
• Patients with C-reactive protein levels higher than 140 mg/L at diagnosis were 2.9 times more likely to have a poor outcome, compared with C-reactive protein level of 140 mg/L or less.
• Patients with white blood cell count greater than 15 x 10⁹ cells/L at diagnosis were 3.7 times more likely to have a poor outcome, compared with those with 15 x 10⁹ cells/L.
• Patients with a longer segment (>86mm) of inflamed colon on CT scan were more likely to have a poor outcome, compared those who had a shorter segment (<65mm).

To help clinicians think about antibiotic treatment in patients with AUD, a recent American Gastroenterological Association clinical practice update provided the following advice: First, antibiotic treatment is advised in patients with uncomplicated diverticulitis who have comorbidities or are frail, who present with refractory symptoms or vomiting, or who have a C-reactive protein level greater than 140 mg/L, or baseline white blood cell count greater than 15 x 10⁹ cells/L.⁵ Also, antibiotic treatment is advised in patients with complicated diverticulitis or uncomplicated diverticulitis with a fluid collection or longer segment of inflammation on CT scan. Finally, patients with uncomplicated diverticulitis who are immunosuppressed are high risk for progression to complicated diverticulitis or sepsis and should be treated with antibiotics.

The lists above clearly leave some patients with AUD who may be managed without antibiotics. These patients are otherwise healthy, have good social support, access to health care, and are experiencing a mild, self-limited episode. Avoiding antibiotics requires shared decision-making with a well-informed patient. I have patients who have embraced this approach, while others found this unacceptable. Given the current level of uncertainty in the literature, I make it my practice to offer antibiotics to any patient who feels strongly about receiving them.

As with many issues in modern medicine, the use of antibiotics in AUD is an unsettled question. Given the known harms of progression of diverticulitis, it is clearly safest to treat patients who were excluded from the small studies we have or flagged by those same studies as being at increased risk of progression. Our uncertainty also demands a shared decision-making model, filling in our patients on what we can and cannot say with confidence. As is often the case, further research is desperately needed. Until that happens, antibiotics for AUD will remain a regular part of my practice.

Anne F. Peery, MD, MSCR, is with the center for gastrointestinal biology and disease at the University of North Carolina at Chapel Hill. She has no conflicts to disclose.

References

1. Daniels L et al. Br J Surg. 2017 Jan;104(1):52-61.

2. Balk EM et al. Management of Colonic Diverticulitis. Comparative Effectiveness Review No. 233. Agency for Healthcare Research and Quality. 2020 Oct. doi: 10.23970/AHRQEPCCER233.

3. Stollman N et al. Gastroenterology. 2015 Dec;149(7):1944-9.

4. Chabok A et al. Br J Surg. 2012 Jan 30;99(4):532-9.

5. Peery AF et al. Gastroenterology. 2021 Feb;160(3):906-11.e1.

The data are robust for withholding more often

That we are engaged in a legitimate debate about the role of antibiotics in acute uncomplicated diverticulitis (AUD) is itself quite notable. In the 1999 American College of Gastroenterology Practice Guidelines,¹ we did not even entertain the concept of withholding antibiotics; the only discussion points were intravenous versus oral. Fast forward 15 years, and in the 2015 American Gastroenterological Association practice guidelines (which the other contributor for this installment of Perspectives, Anne F. Peery, MD, and I worked on together) our first recommendation was that antibiotics should be used “selectively,” rather than routinely.² This did generate some raised eyebrows and hand-wringing in the community, but our position was the result of a rigorous data analysis process and we stood by it.

In fact, Dr. Peery and I also coauthored an accompanying editorial that concluded with an important endorsement “allowing the clinician to consider withholding antibiotics from select uncomplicated patients with mild disease.” I suspect, then, that Dr. Peery and I are very much coincident in our overall thoughts here, and I’m pretty sure that neither of us would defend an “always” or “never” stance on this issue, so for this educational debate, we’re really talking about where in the middle to draw the line (that is, how to define “selectively”). To that end, I will defend the supposition that the subsequent data in support of withholding antibiotics remains robust and even more supportive of this practice in many (but certainly not all) patients with acute, uncomplicated diverticulitis.

The logic underlying selective use was based on two drivers over the past decade, one being an emerging concept that diverticular pathology was often inflammatory rather than solely infectious, coupled with a timely and very important worldwide push toward restraint of antibiotic use. A recent retrospective claims analysis of outpatient antibiotic use for immunocompetent patients with AUD did reported that the dominant antibiotic combination used, metronidazole plus a fluoroquinolone, was associated with an increased risk of Clostridioides difficile infection, compared with the far less frequently used amoxicillin/clavulanate regimen, which highlights that routine antibiotics are not without risk.³

Recently, the U.S. Agency for Healthcare Research and Quality performed a rigorous meta-analysis of this body of evidence, and summarized that “antibiotic treatment may not affect pain symptoms, length of hospital stay, recurrence risk, quality of life, or need for surgery, compared to no antibiotic treatment,” with an admitted low strength of evidence (based on four randomized, controlled trials).⁴

Finally, I’ll close my evidence-based case with a quote from a Clinical Practice Update just published in February 2021 in Gastroenterology: “Antibiotic treatment can be used selectively, rather than routinely, in immunocompetent patients with mild uncomplicated diverticulitis. ... Antibiotic treatment is advised in patients with uncomplicated diverticulitis who have comorbidities or are frail, who present with refractory symptoms or vomiting, or who have a [C-reactive protein] >140 mg/L or baseline [white blood cell count] > 15 x 10⁹. Antibiotic treatment is advised in patients with complicated diverticulitis or uncomplicated diverticulitis with a fluid collection or longer segment of inflammation on CT scan.”⁵ I think this is most excellent advice, providing a practical and clinically useful framework for those in whom antibiotics absolutely should be used, but permitting a fairly large group to avoid antibiotics, which may carry significant harm, based on strong consistent data that does not support a benefit.

So, practically speaking, things are a bit harder for us now when our patient shows up in the ED and if found to have AUD on CT. In the “old days” (that is, the early 2000s), a patient with either clinically suspected or CT-confirmed AUD was simply given antibiotics, mostly a fluoroquinolone, and this was community standard. The only real decision tree was inpatient or outpatient. But now, I would respectfully suggest, we need to invest a bit more time on a nuanced discussion with the potential “no antibiotics” patient (for example, one without immunosuppression, severe comorbidities, or lab or imaging markers of aggressive disease). It is now appropriate to inform such a patient that the data suggest that a conservative approach will not increase their risk of complications and may well spare them antibiotic-related morbidity.

In the context of that informed discussion, factually framed by the practitioner, many patients should (and will, in my experience, although the San Francisco Bay Area may not entirely reflect the country as a whole) choose a strategy of observation. Of course, close follow-up with such patients is required, as is clear reassurance that if things “turn bad” that we’re available and antibiotics remain a salvage option. The “write a script and be done” days are over, and while withholding antibiotics may still feel dangerous or uncomfortable to the patient (or to us), the data is the data, and our patients deserve to at least be offered that option.

Neil Stollman, MD, AGAF, FACG, is chairman of the division of gastroenterology at Alta Bates Summit Medical Center in Oakland, Calif., and an associate clinical professor of medicine in the division of gastroenterology at the University of California, San Francisco. He discloses being a consultant for Cosmo Pharmaceuticals, which has a potential future diverticulitis study of a rifampin-class antibiotic.

References

1. Stollman N and Raskin JB. Am J Gastroenterol. 1999 Nov;94(11):3110-21.

2. Peery AF and Stollman N. Gastroenterology. 2015 Dec;149(7):1944-9.

3. Gaber CE et al. Ann Intern Med. 2021 Feb 23. doi: 10.7326/M20-6315.

4. Balk EM et al. Management of Colonic Diverticulitis. Comparative Effectiveness Review No. 233. Agency for Healthcare Research and Quality. October 2020. doi: 10.23970/AHRQEPCCER233.

5. Peery AF et al. Gastroenterology. 2021 Feb;160(3):906-11.e1.

The Food and Drug Administration granted accelerated approval to the immunotherapy dostarlimab (Jemperli) for the treatment of recurrent or advanced endometrial cancer with deficient mismatch repair (dMMR), which are genetic anomalies abnormalities that disrupt DNA repair.

Usage of the new checkpoint inhibitor is limited to patients who have progressed on or following prior treatment with a platinum-containing chemotherapy. Eligibility must also be determined by an FDA-approved test for the dMMR biomarker. Approximately 25%-30% of patients with advanced endometrial cancer have dMMR tumors, according to the FDA.

The approval is “evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

He explained that the immunotherapy was “specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response.”

The new drug also addresses an unmet medical need, as there are limited therapeutic options in this setting following frontline standard treatment with a platinum-containing chemotherapy.

The approval is based on safety and efficacy data from a single-arm, multicohort clinical trial. Of the 71 patients with dMMR recurrent or advanced endometrial cancer who received dostarlimab, 42.3% had a response. For 93% of that group, the response lasted 6 months or longer.

The drug’s maker, GlaxoSmithKline, is currently conducting additional, larger trials in more patients with dMMR endometrial tumors to verify and further describe clinical benefits.

Common side effects of dostarlimab include fatigue, nausea, diarrhea, anemia, and constipation. Like other checkpoint inhibitors, the new drug can cause immune-mediated side effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

Dostarlimab is contraindicated in women who are pregnant or breastfeeding because it may cause harm to a developing fetus or newborn baby.

The FDA approval comes a month after the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended granting conditional marketing authorization for dostarlimab for use as monotherapy in this same patient group.

In the United States, dostarlimab received Priority Review designation and Breakthrough Therapy designation for this indication.

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

The Food and Drug Administration granted accelerated approval to the immunotherapy dostarlimab (Jemperli) for the treatment of recurrent or advanced endometrial cancer with deficient mismatch repair (dMMR), which are genetic anomalies abnormalities that disrupt DNA repair.

Usage of the new checkpoint inhibitor is limited to patients who have progressed on or following prior treatment with a platinum-containing chemotherapy. Eligibility must also be determined by an FDA-approved test for the dMMR biomarker. Approximately 25%-30% of patients with advanced endometrial cancer have dMMR tumors, according to the FDA.

The approval is “evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

He explained that the immunotherapy was “specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response.”

The new drug also addresses an unmet medical need, as there are limited therapeutic options in this setting following frontline standard treatment with a platinum-containing chemotherapy.

The approval is based on safety and efficacy data from a single-arm, multicohort clinical trial. Of the 71 patients with dMMR recurrent or advanced endometrial cancer who received dostarlimab, 42.3% had a response. For 93% of that group, the response lasted 6 months or longer.

The drug’s maker, GlaxoSmithKline, is currently conducting additional, larger trials in more patients with dMMR endometrial tumors to verify and further describe clinical benefits.

Common side effects of dostarlimab include fatigue, nausea, diarrhea, anemia, and constipation. Like other checkpoint inhibitors, the new drug can cause immune-mediated side effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

Dostarlimab is contraindicated in women who are pregnant or breastfeeding because it may cause harm to a developing fetus or newborn baby.

The FDA approval comes a month after the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended granting conditional marketing authorization for dostarlimab for use as monotherapy in this same patient group.

In the United States, dostarlimab received Priority Review designation and Breakthrough Therapy designation for this indication.

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

The Food and Drug Administration granted accelerated approval to the immunotherapy dostarlimab (Jemperli) for the treatment of recurrent or advanced endometrial cancer with deficient mismatch repair (dMMR), which are genetic anomalies abnormalities that disrupt DNA repair.

Usage of the new checkpoint inhibitor is limited to patients who have progressed on or following prior treatment with a platinum-containing chemotherapy. Eligibility must also be determined by an FDA-approved test for the dMMR biomarker. Approximately 25%-30% of patients with advanced endometrial cancer have dMMR tumors, according to the FDA.

The approval is “evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

He explained that the immunotherapy was “specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response.”

The new drug also addresses an unmet medical need, as there are limited therapeutic options in this setting following frontline standard treatment with a platinum-containing chemotherapy.

The approval is based on safety and efficacy data from a single-arm, multicohort clinical trial. Of the 71 patients with dMMR recurrent or advanced endometrial cancer who received dostarlimab, 42.3% had a response. For 93% of that group, the response lasted 6 months or longer.

The drug’s maker, GlaxoSmithKline, is currently conducting additional, larger trials in more patients with dMMR endometrial tumors to verify and further describe clinical benefits.

Common side effects of dostarlimab include fatigue, nausea, diarrhea, anemia, and constipation. Like other checkpoint inhibitors, the new drug can cause immune-mediated side effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

Dostarlimab is contraindicated in women who are pregnant or breastfeeding because it may cause harm to a developing fetus or newborn baby.

The FDA approval comes a month after the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended granting conditional marketing authorization for dostarlimab for use as monotherapy in this same patient group.

In the United States, dostarlimab received Priority Review designation and Breakthrough Therapy designation for this indication.

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

The federal government’s temporary pause on use of the Johnson & Johnson COVID-19 vaccine last month underscores the significant challenges facing one of the most vulnerable groups – homebound patients.

Courtesy Dr. Peter Gliatto

There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.

Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.

“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”

Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
 

Many roadblocks to vaccination

Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.

“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.

Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.

Courtesy Central Ohio Primary Care

“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.

“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.

Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.

“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
 

Expenses are greater

The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.

Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.

For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.

There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.

William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.

“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”

Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.

“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”

Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.

While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.

Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.

“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
 

Overcoming the challenges

With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24.

Courtesy Central Ohio Primary Care

Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program. 

“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.

People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.

“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.

If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”

Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.

“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.

Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.

The experts interviewed in this article have no conflicts.

Katie Lennon contributed to this report.

This article was updated 4/29/21.

The federal government’s temporary pause on use of the Johnson & Johnson COVID-19 vaccine last month underscores the significant challenges facing one of the most vulnerable groups – homebound patients.

Courtesy Dr. Peter Gliatto

There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.

Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.

“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”

Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
 

Many roadblocks to vaccination

Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.

“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.

Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.

Courtesy Central Ohio Primary Care

“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.

“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.

Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.

“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
 

Expenses are greater

The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.

Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.

For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.

There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.

William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.

“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”

Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.

“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”

Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.

While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.

Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.

“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
 

Overcoming the challenges

With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24.

Courtesy Central Ohio Primary Care

Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program. 

“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.

People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.

“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.

If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”

Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.

“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.

Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.

The experts interviewed in this article have no conflicts.

Katie Lennon contributed to this report.

This article was updated 4/29/21.

The federal government’s temporary pause on use of the Johnson & Johnson COVID-19 vaccine last month underscores the significant challenges facing one of the most vulnerable groups – homebound patients.

Courtesy Dr. Peter Gliatto

There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.

Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.

“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”

Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
 

Many roadblocks to vaccination

Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.

“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.

Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.

Courtesy Central Ohio Primary Care

“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.

“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.

Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.

“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
 

Expenses are greater

The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.

Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.

For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.

There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.

William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.

“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”

Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.

“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”

Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.

While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.

Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.

“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
 

Overcoming the challenges

With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24.

Courtesy Central Ohio Primary Care

Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program. 

“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.

People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.

“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.

If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”

Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.

“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.

Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.

The experts interviewed in this article have no conflicts.

Katie Lennon contributed to this report.

This article was updated 4/29/21.

U.S. Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, will be a keynote speaker at SHM Converge, the Society of Hospital Meidicine’s annual conference.

Dr. Murthy will discuss burnout and well-being in health care, key themes of the conference, during a fireside chat with Danielle Scheurer, MD, MSCR, SFHM, president of SHM’s board of directors. The conversation will be held on Thursday, May 6, 2021 from 1:30 to 2:00 p.m. ET.

“It is an honor to welcome Dr. Murthy back to SHM’s annual conference during a time when his leadership is more important than ever,” said Eric E. Howell, MD, MHM, chief executive officer of SHM. “Dr. Murthy is dedicated to the health of the American people and to the well-being of those who care for them. I know his message will resonate with hospitalists who have been on the front lines of the pandemic since day one. They are key to navigating the future of our nation’s health care system.”

Dr. Murthy has devoted himself to improving public health through service, clinical care, research, education, and entrepreneurship. In addition to clinical practice, Dr. Murthy has two decades of experience in improving health in communities around the world and served as the 19th U.S. Surgeon General from 2014 to 2017, prior to being reappointed with an expanded role earlier in 2021. As “America’s Doctor,” the Surgeon General’s role is to provide clear, consistent guidance and healthcare resources for the public, ensuring to reach the nation’s most vulnerable communities.

“As we guide our nation out of the pandemic, hospitalists can look to Dr. Murthy as a leader and innovator who will do what is best for our hospitalist community and the patients they serve,” Dr. Scheurer said. “Dr. Murthy will provide a unique perspective to help hospitalists care for themselves during a time when they have been hyper-focused on caring for others.”

In addition to Dr. Murthy, SHM Converge will feature three keynote speakers who will address pressing topics in hospital medicine:

• Mark Hertling, DBA: Coming Out of Combat: Post-Pandemic Recovery
• Vineet Arora, MD, MAPP, MHM: Hospitalists Healing: Surviving, Salvaging, Sustaining, and Succeeding for a Pandemic World
• Larry Wellikson, MD, MHM: Out of COVID and Into the Light: Hospitalists More Essential Than Ever

SHM Converge is the premier educational experience for hospital medicine professionals. This year’s virtual conference will be held from May 3-7, 2021 and offers 21 educational tracks, more than 250 speakers, advanced learning courses, networking opportunities, a scientific abstract competition, and more. SHM Converge On Demand is also available until 2024, including the opportunity to earn additional continuing medical education credit.

To register for SHM Converge, visit shmconverge.org. If you are a member of the media who would like to obtain a press pass, email [email protected].

U.S. Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, will be a keynote speaker at SHM Converge, the Society of Hospital Meidicine’s annual conference.

Dr. Murthy will discuss burnout and well-being in health care, key themes of the conference, during a fireside chat with Danielle Scheurer, MD, MSCR, SFHM, president of SHM’s board of directors. The conversation will be held on Thursday, May 6, 2021 from 1:30 to 2:00 p.m. ET.

“It is an honor to welcome Dr. Murthy back to SHM’s annual conference during a time when his leadership is more important than ever,” said Eric E. Howell, MD, MHM, chief executive officer of SHM. “Dr. Murthy is dedicated to the health of the American people and to the well-being of those who care for them. I know his message will resonate with hospitalists who have been on the front lines of the pandemic since day one. They are key to navigating the future of our nation’s health care system.”

Dr. Murthy has devoted himself to improving public health through service, clinical care, research, education, and entrepreneurship. In addition to clinical practice, Dr. Murthy has two decades of experience in improving health in communities around the world and served as the 19th U.S. Surgeon General from 2014 to 2017, prior to being reappointed with an expanded role earlier in 2021. As “America’s Doctor,” the Surgeon General’s role is to provide clear, consistent guidance and healthcare resources for the public, ensuring to reach the nation’s most vulnerable communities.

“As we guide our nation out of the pandemic, hospitalists can look to Dr. Murthy as a leader and innovator who will do what is best for our hospitalist community and the patients they serve,” Dr. Scheurer said. “Dr. Murthy will provide a unique perspective to help hospitalists care for themselves during a time when they have been hyper-focused on caring for others.”

In addition to Dr. Murthy, SHM Converge will feature three keynote speakers who will address pressing topics in hospital medicine:

• Mark Hertling, DBA: Coming Out of Combat: Post-Pandemic Recovery
• Vineet Arora, MD, MAPP, MHM: Hospitalists Healing: Surviving, Salvaging, Sustaining, and Succeeding for a Pandemic World
• Larry Wellikson, MD, MHM: Out of COVID and Into the Light: Hospitalists More Essential Than Ever

SHM Converge is the premier educational experience for hospital medicine professionals. This year’s virtual conference will be held from May 3-7, 2021 and offers 21 educational tracks, more than 250 speakers, advanced learning courses, networking opportunities, a scientific abstract competition, and more. SHM Converge On Demand is also available until 2024, including the opportunity to earn additional continuing medical education credit.

To register for SHM Converge, visit shmconverge.org. If you are a member of the media who would like to obtain a press pass, email [email protected].

U.S. Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, will be a keynote speaker at SHM Converge, the Society of Hospital Meidicine’s annual conference.

Dr. Murthy will discuss burnout and well-being in health care, key themes of the conference, during a fireside chat with Danielle Scheurer, MD, MSCR, SFHM, president of SHM’s board of directors. The conversation will be held on Thursday, May 6, 2021 from 1:30 to 2:00 p.m. ET.

“It is an honor to welcome Dr. Murthy back to SHM’s annual conference during a time when his leadership is more important than ever,” said Eric E. Howell, MD, MHM, chief executive officer of SHM. “Dr. Murthy is dedicated to the health of the American people and to the well-being of those who care for them. I know his message will resonate with hospitalists who have been on the front lines of the pandemic since day one. They are key to navigating the future of our nation’s health care system.”

Dr. Murthy has devoted himself to improving public health through service, clinical care, research, education, and entrepreneurship. In addition to clinical practice, Dr. Murthy has two decades of experience in improving health in communities around the world and served as the 19th U.S. Surgeon General from 2014 to 2017, prior to being reappointed with an expanded role earlier in 2021. As “America’s Doctor,” the Surgeon General’s role is to provide clear, consistent guidance and healthcare resources for the public, ensuring to reach the nation’s most vulnerable communities.

“As we guide our nation out of the pandemic, hospitalists can look to Dr. Murthy as a leader and innovator who will do what is best for our hospitalist community and the patients they serve,” Dr. Scheurer said. “Dr. Murthy will provide a unique perspective to help hospitalists care for themselves during a time when they have been hyper-focused on caring for others.”

In addition to Dr. Murthy, SHM Converge will feature three keynote speakers who will address pressing topics in hospital medicine:

• Mark Hertling, DBA: Coming Out of Combat: Post-Pandemic Recovery
• Vineet Arora, MD, MAPP, MHM: Hospitalists Healing: Surviving, Salvaging, Sustaining, and Succeeding for a Pandemic World
• Larry Wellikson, MD, MHM: Out of COVID and Into the Light: Hospitalists More Essential Than Ever

SHM Converge is the premier educational experience for hospital medicine professionals. This year’s virtual conference will be held from May 3-7, 2021 and offers 21 educational tracks, more than 250 speakers, advanced learning courses, networking opportunities, a scientific abstract competition, and more. SHM Converge On Demand is also available until 2024, including the opportunity to earn additional continuing medical education credit.

To register for SHM Converge, visit shmconverge.org. If you are a member of the media who would like to obtain a press pass, email [email protected].

Therapy-related acute myeloid leukemia (t-AML) occurs as a complication of chemotherapy and/or radiotherapy for previous cancer or for nonmalignant disorders, with an estimated prevalence of 10%-15% of all AML cases, according to Ram Vasudevan Nampoothiri, MD, and colleagues at the Princess Margaret Cancer Center, University of Toronto.

The Armed Forces Institute of Pathology/Public Domain

Dr. Nampoothiri and colleagues performed a retrospective study of 68 patients with t-AML who underwent hematopoietic stem cell transplantation (HSCT) at their institution. They found significant predictors of reduced overall survival, including chromosomal rearrangements, induction regimens, donor type, patient performance status, and the type of graft-versus-host disease (GVHD) prophylaxis the patients received, as reported in Hematology/Oncology and Stem Cell Therapy.
 

Some populations benefit

Among the 68 patients studied, a total of 59.9% were women; and the median age was 56.5 years. All patients were analyzed for prior malignancy, therapy, time to diagnosis of t-AML, transplant details, relapse-free survival, overall survival, and predictors of outcomes.

At 2 years, the cumulative incidence of relapse, nonrelapse mortality, relapse-free survival, and overall survival were 17.9%, 34.5%, 47.6%, and 49.3%, respectively. Overall, acute and chronic GVHD occurred in 39 (57.4%) and 23 (33.8%) patients, respectively, according to the researchers.

The significant predictors of reduced overall survival were the presence of the 11q23 chromosomal rearrangement (hazard ratio, 3.24), use of induction regimens other than fludarabine, cytarabine, idarubicin, and granulocyte colony-stimulating factor or 7 + 3 (HR, 3.65), use of haploidentical donors (HR, 3.48), an Eastern Cooperative Oncology Group performance status of 2 or higher (HR, 5.83), and use of cyclosporine A–methotrexate as GVHD prophylaxis (HR, 2.41).

The researchers also found that a significant decrease in survival was seen with an increasing number of any of these prognostic factors.
 

A growing need

The incidence of t-AML is increasing because of longer life expectancy of the general population and also because of the improved survival of patients treated with chemotherapy and/or radiation for prior malignancies, according to the researchers.

They concluded that, even with this increasing prevalence and normally poor prognosis, “patients of t-AML having good-risk karyotypes, good performance status, and having HLA-matched donors have favorable outcomes after allo-HSCT.”

The authors reported that they had no competing financial interests.

[email protected]

Therapy-related acute myeloid leukemia (t-AML) occurs as a complication of chemotherapy and/or radiotherapy for previous cancer or for nonmalignant disorders, with an estimated prevalence of 10%-15% of all AML cases, according to Ram Vasudevan Nampoothiri, MD, and colleagues at the Princess Margaret Cancer Center, University of Toronto.

The Armed Forces Institute of Pathology/Public Domain

Dr. Nampoothiri and colleagues performed a retrospective study of 68 patients with t-AML who underwent hematopoietic stem cell transplantation (HSCT) at their institution. They found significant predictors of reduced overall survival, including chromosomal rearrangements, induction regimens, donor type, patient performance status, and the type of graft-versus-host disease (GVHD) prophylaxis the patients received, as reported in Hematology/Oncology and Stem Cell Therapy.
 

Some populations benefit

Among the 68 patients studied, a total of 59.9% were women; and the median age was 56.5 years. All patients were analyzed for prior malignancy, therapy, time to diagnosis of t-AML, transplant details, relapse-free survival, overall survival, and predictors of outcomes.

At 2 years, the cumulative incidence of relapse, nonrelapse mortality, relapse-free survival, and overall survival were 17.9%, 34.5%, 47.6%, and 49.3%, respectively. Overall, acute and chronic GVHD occurred in 39 (57.4%) and 23 (33.8%) patients, respectively, according to the researchers.

The significant predictors of reduced overall survival were the presence of the 11q23 chromosomal rearrangement (hazard ratio, 3.24), use of induction regimens other than fludarabine, cytarabine, idarubicin, and granulocyte colony-stimulating factor or 7 + 3 (HR, 3.65), use of haploidentical donors (HR, 3.48), an Eastern Cooperative Oncology Group performance status of 2 or higher (HR, 5.83), and use of cyclosporine A–methotrexate as GVHD prophylaxis (HR, 2.41).

The researchers also found that a significant decrease in survival was seen with an increasing number of any of these prognostic factors.
 

A growing need

The incidence of t-AML is increasing because of longer life expectancy of the general population and also because of the improved survival of patients treated with chemotherapy and/or radiation for prior malignancies, according to the researchers.

They concluded that, even with this increasing prevalence and normally poor prognosis, “patients of t-AML having good-risk karyotypes, good performance status, and having HLA-matched donors have favorable outcomes after allo-HSCT.”

The authors reported that they had no competing financial interests.

[email protected]

Therapy-related acute myeloid leukemia (t-AML) occurs as a complication of chemotherapy and/or radiotherapy for previous cancer or for nonmalignant disorders, with an estimated prevalence of 10%-15% of all AML cases, according to Ram Vasudevan Nampoothiri, MD, and colleagues at the Princess Margaret Cancer Center, University of Toronto.

The Armed Forces Institute of Pathology/Public Domain

Dr. Nampoothiri and colleagues performed a retrospective study of 68 patients with t-AML who underwent hematopoietic stem cell transplantation (HSCT) at their institution. They found significant predictors of reduced overall survival, including chromosomal rearrangements, induction regimens, donor type, patient performance status, and the type of graft-versus-host disease (GVHD) prophylaxis the patients received, as reported in Hematology/Oncology and Stem Cell Therapy.
 

Some populations benefit

Among the 68 patients studied, a total of 59.9% were women; and the median age was 56.5 years. All patients were analyzed for prior malignancy, therapy, time to diagnosis of t-AML, transplant details, relapse-free survival, overall survival, and predictors of outcomes.

At 2 years, the cumulative incidence of relapse, nonrelapse mortality, relapse-free survival, and overall survival were 17.9%, 34.5%, 47.6%, and 49.3%, respectively. Overall, acute and chronic GVHD occurred in 39 (57.4%) and 23 (33.8%) patients, respectively, according to the researchers.

The significant predictors of reduced overall survival were the presence of the 11q23 chromosomal rearrangement (hazard ratio, 3.24), use of induction regimens other than fludarabine, cytarabine, idarubicin, and granulocyte colony-stimulating factor or 7 + 3 (HR, 3.65), use of haploidentical donors (HR, 3.48), an Eastern Cooperative Oncology Group performance status of 2 or higher (HR, 5.83), and use of cyclosporine A–methotrexate as GVHD prophylaxis (HR, 2.41).

The researchers also found that a significant decrease in survival was seen with an increasing number of any of these prognostic factors.
 

A growing need

The incidence of t-AML is increasing because of longer life expectancy of the general population and also because of the improved survival of patients treated with chemotherapy and/or radiation for prior malignancies, according to the researchers.

They concluded that, even with this increasing prevalence and normally poor prognosis, “patients of t-AML having good-risk karyotypes, good performance status, and having HLA-matched donors have favorable outcomes after allo-HSCT.”

The authors reported that they had no competing financial interests.

[email protected]

Hispanic diabetes patients are significantly less likely than Black or White patients to receive preventive guideline-based care soon after diagnosis, based on data from more than 7,000 individuals.

Racial and ethnic disparities in diabetes care remain a pervasive health problem, and minorities including non-Hispanic Blacks and Hispanics experience higher rates of complications, including retinopathy and neuropathy, compared with other groups, Felippe Ottoni Marcondes, MD, of Massachusetts General Hospital, Boston, and colleagues noted in a poster presented at the annual meeting of the Society for General Internal Medicine.

Data from previous studies have shown that diabetes patients who receive guideline-directed preventive care soon after diagnosis can reduce their risk of complications, they said.

To identify disparities in the provision of guideline-directed preventive care, the researchers analyzed data from 7,341 individuals who participated in the National Health Interview Survey from 2011 to 2017. They reviewed associations between race/ethnicity and visits to an eye specialist, a foot specialist, and checks of blood pressure and cholesterol in the past year among individuals diagnosed with diabetes within the past 5 years.

Overall, Hispanics had significantly lower rates of insurance coverage (75.9%), compared with non-Hispanic Whites (93.2%) and non-Hispanic Blacks (88.1%; P < .001).

Hispanics also were significantly less likely than Whites to have had a prior year eye exam (odds ratio, 0.80) and blood pressure check (OR, 0.45), after controlling for variables including age, sex, socioeconomic status, health insurance, general health status, U.S. region, marital status, body mass index, and various comorbidities.

Although insurance coverage mediated 42.8% of the total effect of race/ethnicity on annual eye specialist visits for Hispanics as compared with Whites, there was no significant effect for Blacks, compared with Whites.
 

COVID concerns impact diabetes disparities

“As the diabetes epidemic continues in the U.S., it is important to bring to the front of the diabetes care conversation racial/ethnic disparities that persisted or have been only partially addressed,” Dr. Marcondes said in an interview. “It is also important to emphasize that patients with diabetes are at higher risk for COVID-19 hospitalizations, complications, and death, and COVID-19 has disproportionately affected racial/ethnic minorities, so racial/ethnic minorities with diabetes have compounded risk of complications not only from diabetes but also from COVID-19.

“Importantly, our study highlights disparities in health care that are likely the product of systemic inequalities in access to care and insurance coverage at a moment when conversations about the race/racism and their health impact are fresh in the minds of public and health policy officials and the general public,” he emphasized.

“Unfortunately, I cannot say that I am surprised by our findings,” Dr. Marcondes said. “We expected to see some differences in the receipt of care for racial/ethnic minorities compared to white individuals for those recently diagnosed with diabetes, and that is exactly what our findings show.”

However, “what was perhaps intriguing is that disparities in the receipt of guideline-directed care were greater for Hispanic compared to White individuals than for Black compared to White individuals,” said Dr. Marcondes. “The causes of these differences are many. Hispanic individuals are less likely than White and Black persons to have insurance coverage.” Other unmeasured factors include language barriers that Hispanic individuals may face, as well as the bias and discrimination experienced by Hispanic and Black individuals alike.
 

Focus on equitable early intervention

“There is plenty of evidence in the medical literature that Black and Hispanic individuals with diabetes, as well as other minorities, have higher risk of complications of diabetes such as retinopathy, nephropathy, as well as cardiovascular risk factors such as high blood pressure and cholesterol,” Dr. Marcondes said. “Yet, complications in the time that immediately follows the diagnosis of diabetes are likely to be low.”

To reduce the risk of complications in the future, “physicians and health providers need to focus on providing equitable, guideline-directed treatment for their minority patients recently diagnosed with diabetes,” Dr. Marcondes emphasized. “Intervening early in the disease course will hopefully lead to a decrease in the rate of complications for racial/ethnic minorities. Clinicians, especially primary care physicians and providers, need to be aware that they are often the first encounter of many patients with the health care system. Effective communication and unbiased language on the part of clinicians will lead to stronger patient-physician relationships that foster opportunity to discuss disease prevention.

“Additional research is needed to evaluate the attitudes and biases of primary care providers and access the impact of patient navigation resources when treating minority patients with diabetes,” he concluded.

Digging Deeper into Disparities
“In diabetes, there are known racial and ethnic disparities such that minorities receive suboptimal screening and treatment, and have worse outcomes,” said Scott J. Pilla, MD, of The Johns Hopkins University School of Medicine, Baltimore, in an interview. 

“This study examines disparities in diabetes preventive measures in the U.S. using a national survey (NHIS) over the past decade. They took the important step of stratifying their analyses by health insurance and socioeconomic status which, in addition to race, may have a large impact,” said Dr. Pilla. However, “One critique of the poster is that it is unclear whether the researchers weighted their analyses to account for the nationally representative sampling of the NHIS survey,” he noted. 
Dr. Pilla said the finding that Hispanic patients had fewer diabetes preventive measures lines up with previous research in this area. 

“I was surprised that the disparities did not extend to black patients, who have been found to also receive suboptimal care compared to white patients in other studies,” he noted. 

The message for clinical practice: “Minorities with diabetes are at a higher risk of adverse diabetes outcomes and may need extra support and resources to achieve their evidence-based diabetes prevention,” Dr. Pilla said. 

“More research is needed to understand the root cause of racial and ethnic disparities in diabetes management to tease apart possible contributors including health insurance coverage, socioeconomic factors, cultural and community factors, and systemic racism. This will help inform targeted approaches to reducing disparities in diabetes care,” he emphasized.

The researchers had no relevant financial conflicts to disclose. Dr. Pilla had no financial conflicts to disclose. 

Hispanic diabetes patients are significantly less likely than Black or White patients to receive preventive guideline-based care soon after diagnosis, based on data from more than 7,000 individuals.

Racial and ethnic disparities in diabetes care remain a pervasive health problem, and minorities including non-Hispanic Blacks and Hispanics experience higher rates of complications, including retinopathy and neuropathy, compared with other groups, Felippe Ottoni Marcondes, MD, of Massachusetts General Hospital, Boston, and colleagues noted in a poster presented at the annual meeting of the Society for General Internal Medicine.

Data from previous studies have shown that diabetes patients who receive guideline-directed preventive care soon after diagnosis can reduce their risk of complications, they said.

To identify disparities in the provision of guideline-directed preventive care, the researchers analyzed data from 7,341 individuals who participated in the National Health Interview Survey from 2011 to 2017. They reviewed associations between race/ethnicity and visits to an eye specialist, a foot specialist, and checks of blood pressure and cholesterol in the past year among individuals diagnosed with diabetes within the past 5 years.

Overall, Hispanics had significantly lower rates of insurance coverage (75.9%), compared with non-Hispanic Whites (93.2%) and non-Hispanic Blacks (88.1%; P < .001).

Hispanics also were significantly less likely than Whites to have had a prior year eye exam (odds ratio, 0.80) and blood pressure check (OR, 0.45), after controlling for variables including age, sex, socioeconomic status, health insurance, general health status, U.S. region, marital status, body mass index, and various comorbidities.

Although insurance coverage mediated 42.8% of the total effect of race/ethnicity on annual eye specialist visits for Hispanics as compared with Whites, there was no significant effect for Blacks, compared with Whites.
 

COVID concerns impact diabetes disparities

“As the diabetes epidemic continues in the U.S., it is important to bring to the front of the diabetes care conversation racial/ethnic disparities that persisted or have been only partially addressed,” Dr. Marcondes said in an interview. “It is also important to emphasize that patients with diabetes are at higher risk for COVID-19 hospitalizations, complications, and death, and COVID-19 has disproportionately affected racial/ethnic minorities, so racial/ethnic minorities with diabetes have compounded risk of complications not only from diabetes but also from COVID-19.

“Importantly, our study highlights disparities in health care that are likely the product of systemic inequalities in access to care and insurance coverage at a moment when conversations about the race/racism and their health impact are fresh in the minds of public and health policy officials and the general public,” he emphasized.

“Unfortunately, I cannot say that I am surprised by our findings,” Dr. Marcondes said. “We expected to see some differences in the receipt of care for racial/ethnic minorities compared to white individuals for those recently diagnosed with diabetes, and that is exactly what our findings show.”

However, “what was perhaps intriguing is that disparities in the receipt of guideline-directed care were greater for Hispanic compared to White individuals than for Black compared to White individuals,” said Dr. Marcondes. “The causes of these differences are many. Hispanic individuals are less likely than White and Black persons to have insurance coverage.” Other unmeasured factors include language barriers that Hispanic individuals may face, as well as the bias and discrimination experienced by Hispanic and Black individuals alike.
 

Focus on equitable early intervention

“There is plenty of evidence in the medical literature that Black and Hispanic individuals with diabetes, as well as other minorities, have higher risk of complications of diabetes such as retinopathy, nephropathy, as well as cardiovascular risk factors such as high blood pressure and cholesterol,” Dr. Marcondes said. “Yet, complications in the time that immediately follows the diagnosis of diabetes are likely to be low.”

To reduce the risk of complications in the future, “physicians and health providers need to focus on providing equitable, guideline-directed treatment for their minority patients recently diagnosed with diabetes,” Dr. Marcondes emphasized. “Intervening early in the disease course will hopefully lead to a decrease in the rate of complications for racial/ethnic minorities. Clinicians, especially primary care physicians and providers, need to be aware that they are often the first encounter of many patients with the health care system. Effective communication and unbiased language on the part of clinicians will lead to stronger patient-physician relationships that foster opportunity to discuss disease prevention.

“Additional research is needed to evaluate the attitudes and biases of primary care providers and access the impact of patient navigation resources when treating minority patients with diabetes,” he concluded.

Digging Deeper into Disparities
“In diabetes, there are known racial and ethnic disparities such that minorities receive suboptimal screening and treatment, and have worse outcomes,” said Scott J. Pilla, MD, of The Johns Hopkins University School of Medicine, Baltimore, in an interview. 

“This study examines disparities in diabetes preventive measures in the U.S. using a national survey (NHIS) over the past decade. They took the important step of stratifying their analyses by health insurance and socioeconomic status which, in addition to race, may have a large impact,” said Dr. Pilla. However, “One critique of the poster is that it is unclear whether the researchers weighted their analyses to account for the nationally representative sampling of the NHIS survey,” he noted. 
Dr. Pilla said the finding that Hispanic patients had fewer diabetes preventive measures lines up with previous research in this area. 

“I was surprised that the disparities did not extend to black patients, who have been found to also receive suboptimal care compared to white patients in other studies,” he noted. 

The message for clinical practice: “Minorities with diabetes are at a higher risk of adverse diabetes outcomes and may need extra support and resources to achieve their evidence-based diabetes prevention,” Dr. Pilla said. 

“More research is needed to understand the root cause of racial and ethnic disparities in diabetes management to tease apart possible contributors including health insurance coverage, socioeconomic factors, cultural and community factors, and systemic racism. This will help inform targeted approaches to reducing disparities in diabetes care,” he emphasized.

The researchers had no relevant financial conflicts to disclose. Dr. Pilla had no financial conflicts to disclose. 

Hispanic diabetes patients are significantly less likely than Black or White patients to receive preventive guideline-based care soon after diagnosis, based on data from more than 7,000 individuals.

Racial and ethnic disparities in diabetes care remain a pervasive health problem, and minorities including non-Hispanic Blacks and Hispanics experience higher rates of complications, including retinopathy and neuropathy, compared with other groups, Felippe Ottoni Marcondes, MD, of Massachusetts General Hospital, Boston, and colleagues noted in a poster presented at the annual meeting of the Society for General Internal Medicine.

Data from previous studies have shown that diabetes patients who receive guideline-directed preventive care soon after diagnosis can reduce their risk of complications, they said.

To identify disparities in the provision of guideline-directed preventive care, the researchers analyzed data from 7,341 individuals who participated in the National Health Interview Survey from 2011 to 2017. They reviewed associations between race/ethnicity and visits to an eye specialist, a foot specialist, and checks of blood pressure and cholesterol in the past year among individuals diagnosed with diabetes within the past 5 years.

Overall, Hispanics had significantly lower rates of insurance coverage (75.9%), compared with non-Hispanic Whites (93.2%) and non-Hispanic Blacks (88.1%; P < .001).

Hispanics also were significantly less likely than Whites to have had a prior year eye exam (odds ratio, 0.80) and blood pressure check (OR, 0.45), after controlling for variables including age, sex, socioeconomic status, health insurance, general health status, U.S. region, marital status, body mass index, and various comorbidities.

Although insurance coverage mediated 42.8% of the total effect of race/ethnicity on annual eye specialist visits for Hispanics as compared with Whites, there was no significant effect for Blacks, compared with Whites.
 

COVID concerns impact diabetes disparities

“As the diabetes epidemic continues in the U.S., it is important to bring to the front of the diabetes care conversation racial/ethnic disparities that persisted or have been only partially addressed,” Dr. Marcondes said in an interview. “It is also important to emphasize that patients with diabetes are at higher risk for COVID-19 hospitalizations, complications, and death, and COVID-19 has disproportionately affected racial/ethnic minorities, so racial/ethnic minorities with diabetes have compounded risk of complications not only from diabetes but also from COVID-19.

“Importantly, our study highlights disparities in health care that are likely the product of systemic inequalities in access to care and insurance coverage at a moment when conversations about the race/racism and their health impact are fresh in the minds of public and health policy officials and the general public,” he emphasized.

“Unfortunately, I cannot say that I am surprised by our findings,” Dr. Marcondes said. “We expected to see some differences in the receipt of care for racial/ethnic minorities compared to white individuals for those recently diagnosed with diabetes, and that is exactly what our findings show.”

However, “what was perhaps intriguing is that disparities in the receipt of guideline-directed care were greater for Hispanic compared to White individuals than for Black compared to White individuals,” said Dr. Marcondes. “The causes of these differences are many. Hispanic individuals are less likely than White and Black persons to have insurance coverage.” Other unmeasured factors include language barriers that Hispanic individuals may face, as well as the bias and discrimination experienced by Hispanic and Black individuals alike.
 

Focus on equitable early intervention

“There is plenty of evidence in the medical literature that Black and Hispanic individuals with diabetes, as well as other minorities, have higher risk of complications of diabetes such as retinopathy, nephropathy, as well as cardiovascular risk factors such as high blood pressure and cholesterol,” Dr. Marcondes said. “Yet, complications in the time that immediately follows the diagnosis of diabetes are likely to be low.”

To reduce the risk of complications in the future, “physicians and health providers need to focus on providing equitable, guideline-directed treatment for their minority patients recently diagnosed with diabetes,” Dr. Marcondes emphasized. “Intervening early in the disease course will hopefully lead to a decrease in the rate of complications for racial/ethnic minorities. Clinicians, especially primary care physicians and providers, need to be aware that they are often the first encounter of many patients with the health care system. Effective communication and unbiased language on the part of clinicians will lead to stronger patient-physician relationships that foster opportunity to discuss disease prevention.

“Additional research is needed to evaluate the attitudes and biases of primary care providers and access the impact of patient navigation resources when treating minority patients with diabetes,” he concluded.

Digging Deeper into Disparities
“In diabetes, there are known racial and ethnic disparities such that minorities receive suboptimal screening and treatment, and have worse outcomes,” said Scott J. Pilla, MD, of The Johns Hopkins University School of Medicine, Baltimore, in an interview. 

“This study examines disparities in diabetes preventive measures in the U.S. using a national survey (NHIS) over the past decade. They took the important step of stratifying their analyses by health insurance and socioeconomic status which, in addition to race, may have a large impact,” said Dr. Pilla. However, “One critique of the poster is that it is unclear whether the researchers weighted their analyses to account for the nationally representative sampling of the NHIS survey,” he noted. 
Dr. Pilla said the finding that Hispanic patients had fewer diabetes preventive measures lines up with previous research in this area. 

“I was surprised that the disparities did not extend to black patients, who have been found to also receive suboptimal care compared to white patients in other studies,” he noted. 

The message for clinical practice: “Minorities with diabetes are at a higher risk of adverse diabetes outcomes and may need extra support and resources to achieve their evidence-based diabetes prevention,” Dr. Pilla said. 

“More research is needed to understand the root cause of racial and ethnic disparities in diabetes management to tease apart possible contributors including health insurance coverage, socioeconomic factors, cultural and community factors, and systemic racism. This will help inform targeted approaches to reducing disparities in diabetes care,” he emphasized.

The researchers had no relevant financial conflicts to disclose. Dr. Pilla had no financial conflicts to disclose. 

COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.

Floaria Bicher/iStock/Getty Images Plus

“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.

The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.

“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.

The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.

The initial findings from the registry were published online in the Journal of the American College of Cardiology.
 

Atypical symptoms may explain high death rate

The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls). 

This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.

The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.

These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.

The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.

COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.

Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).

The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.

Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.

“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.  

“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.

Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.

Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.

This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.

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

COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.

Floaria Bicher/iStock/Getty Images Plus

“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.

The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.

“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.

The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.

The initial findings from the registry were published online in the Journal of the American College of Cardiology.
 

Atypical symptoms may explain high death rate

The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls). 

This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.

The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.

These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.

The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.

COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.

Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).

The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.

Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.

“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.  

“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.

Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.

Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.

This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.

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

COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.

Floaria Bicher/iStock/Getty Images Plus

“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.

The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.

“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.

The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.

The initial findings from the registry were published online in the Journal of the American College of Cardiology.
 

Atypical symptoms may explain high death rate

The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls). 

This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.

The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.

These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.

The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.

COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.

Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).

The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.

Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.

“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.  

“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.

Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.

Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.

This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.

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

The United States Preventive Services Task Force recently released a draft of updated recommendations for screening for prediabetes and type 2 diabetes mellitus (DM). If accepted as written, the new recommendation will be to “screen all asymptomatic adults ages 35 to 70 years who are overweight or obese.” Upon diagnosis of prediabetes, the recommendation is to offer or refer patients to preventive interventions.

This new recommendation would replace the one from 2015, which recommended screening adults aged 40-70 who are overweight or obese, lowering the age at which screening begins by 5 years. It would also replace the recommendation of referral to intensive behavioral counseling to promote a healthy diet and exercise.¹

The American Diabetes Association (ADA) identifies A1c, fasting plasma glucose, or oral glucose tolerance tests as appropriate tests for the diagnosis of prediabetes and type 2 DM, and the new draft recommendation does not provide a preference for method of screening.²

The USPSTF’s draft recommendation could expand screening with the hope of identifying patients with prediabetes, or those with diabetes who are asymptomatic, with the intent of beginning treatment before there are serious complications.
 

Unknown diabetes or prediabetes diagnosis common

It has been estimated by the Centers for Disease Control and Prevention that 12% of U.S. adults had DM as of 2015, though nearly 24% were not aware that they had it. Also, according to the CDC, the prevalence of DM increases with age and is higher in those with less than a high school education. The same report indicates that more than 30% of U.S. adults have prediabetes, and with less than 12% of those individuals are aware of it.³ A possible explanation for a patient’s being unaware of a diagnosis could be that it has been documented in a chart but the patient does not know such information is in his or her health record. According to the evidence provided for the updated recommendation, earlier diagnosis may have an important benefit in preventing serious complications.

A modeling study compared simulated screening strategies and found that the most optimal screening strategy from a cost-effectiveness perspective begins between the ages of 30 and 45, with rescreening every 3-5 years. Further models have led researchers to conclude that early diagnosis can lead to decreased cardiovascular events as well as an opportunity for multifactorial treatment.¹ For this reason, it makes sense to expand the ages of screening for obese and overweight individuals.
 

Treatment recommendations are more flexible

The change in treatment recommendations for a new diagnosis of prediabetes is potentially more useful. It may not be feasible or reasonable for physicians to always provide or refer their patients for intensive behavior interventions. The updated recommendation would allow for the inclusion of not only behavioral counseling and health education, but also potential medication options that are currently available but not approved, or that may be available in the future. The evidence review seemed to be mixed in outcome in this area, so the increased flexibility will likely allow for future opportunities.

Screening criteria may be too narrow

This recommendation, does not, however, provide any guidance on screening of individuals who have other risk factors besides a body mass index consistent with overweight or obesity. It seems that this may be a missed opportunity.

The draft statement clearly indicates that there are other factors associated with increased risk of developing DM, but does not consider these factors in determining which patients should be screened. Both the ADA and the American Association of Clinical Endocrinology (AACE) have recommendations for universal screening for all adults 45 and older, acknowledging that incidence of DM increases with age. The ADA also recommends screening individuals who are overweight or obese and have an additional risk factor regardless of age. The AACE recommends screening all individuals for risk factors regardless of age.

The current and draft recommendations by the USPSTF do not address other risk factors and indicate only that further research is needed to understand the risk associated with DM and the natural history of pre-DM and who may progress to DM or revert to normoglycemia. Without comment on other risk factors or universal screening with age, the USPSTF recommendation potentially would not be sensitive enough to capture all those who may meet criteria for prediabetes or DM.^2,4

In addition to not addressing other risk factors and screening for those of normal and underweight BMI, the USPSTF recommendation does not address frequency of screening. The recommendations from both the ADA and the AACE indicate screening at 3-year intervals for those who are eligible – for any reason. The supporting evidence review did not seem to address this aspect, and so it is understandable that there was no comment. However, I feel this will lead physicians to turn to the other guidelines for guidance where there is disagreement in other aspects.

Ultimately, the draft updated recommendation will provide physicians with the opportunity to identify more patients with prediabetes and DM. This will be wonderful in terms of being able to offer treatments and lifestyle interventions to decrease the morbidity patients would face were these conditions not diagnosed. I hope that future recommendations will also address risk factors in addition to BMI as well as frequency of screening for those who remain at increased risk but initially screen negative.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

1. Screening for prediabetes and type 2 diabetes mellitus. U.S. Preventive Services Task Force. 2021 Mar 16.

2. Classification and diagnosis of diabetes: Standards of medical care in diabetes – 2020. American Diabetes Association. Diabetes Care. 2020 Jan. doi: 10.2337/dc20-S002.

3. National Diabetes Statistics Report, 2020. Centers for Disease Control and Prevention.

4. American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan. Hadelsman Y et al. Endocr Pract. 2015 Apr. 1-87. doi: 10.4158/EP15672.GL.

The United States Preventive Services Task Force recently released a draft of updated recommendations for screening for prediabetes and type 2 diabetes mellitus (DM). If accepted as written, the new recommendation will be to “screen all asymptomatic adults ages 35 to 70 years who are overweight or obese.” Upon diagnosis of prediabetes, the recommendation is to offer or refer patients to preventive interventions.

This new recommendation would replace the one from 2015, which recommended screening adults aged 40-70 who are overweight or obese, lowering the age at which screening begins by 5 years. It would also replace the recommendation of referral to intensive behavioral counseling to promote a healthy diet and exercise.¹

The American Diabetes Association (ADA) identifies A1c, fasting plasma glucose, or oral glucose tolerance tests as appropriate tests for the diagnosis of prediabetes and type 2 DM, and the new draft recommendation does not provide a preference for method of screening.²

The USPSTF’s draft recommendation could expand screening with the hope of identifying patients with prediabetes, or those with diabetes who are asymptomatic, with the intent of beginning treatment before there are serious complications.
 

Unknown diabetes or prediabetes diagnosis common

It has been estimated by the Centers for Disease Control and Prevention that 12% of U.S. adults had DM as of 2015, though nearly 24% were not aware that they had it. Also, according to the CDC, the prevalence of DM increases with age and is higher in those with less than a high school education. The same report indicates that more than 30% of U.S. adults have prediabetes, and with less than 12% of those individuals are aware of it.³ A possible explanation for a patient’s being unaware of a diagnosis could be that it has been documented in a chart but the patient does not know such information is in his or her health record. According to the evidence provided for the updated recommendation, earlier diagnosis may have an important benefit in preventing serious complications.

A modeling study compared simulated screening strategies and found that the most optimal screening strategy from a cost-effectiveness perspective begins between the ages of 30 and 45, with rescreening every 3-5 years. Further models have led researchers to conclude that early diagnosis can lead to decreased cardiovascular events as well as an opportunity for multifactorial treatment.¹ For this reason, it makes sense to expand the ages of screening for obese and overweight individuals.
 

Treatment recommendations are more flexible

The change in treatment recommendations for a new diagnosis of prediabetes is potentially more useful. It may not be feasible or reasonable for physicians to always provide or refer their patients for intensive behavior interventions. The updated recommendation would allow for the inclusion of not only behavioral counseling and health education, but also potential medication options that are currently available but not approved, or that may be available in the future. The evidence review seemed to be mixed in outcome in this area, so the increased flexibility will likely allow for future opportunities.

Screening criteria may be too narrow

This recommendation, does not, however, provide any guidance on screening of individuals who have other risk factors besides a body mass index consistent with overweight or obesity. It seems that this may be a missed opportunity.

The draft statement clearly indicates that there are other factors associated with increased risk of developing DM, but does not consider these factors in determining which patients should be screened. Both the ADA and the American Association of Clinical Endocrinology (AACE) have recommendations for universal screening for all adults 45 and older, acknowledging that incidence of DM increases with age. The ADA also recommends screening individuals who are overweight or obese and have an additional risk factor regardless of age. The AACE recommends screening all individuals for risk factors regardless of age.

The current and draft recommendations by the USPSTF do not address other risk factors and indicate only that further research is needed to understand the risk associated with DM and the natural history of pre-DM and who may progress to DM or revert to normoglycemia. Without comment on other risk factors or universal screening with age, the USPSTF recommendation potentially would not be sensitive enough to capture all those who may meet criteria for prediabetes or DM.^2,4

In addition to not addressing other risk factors and screening for those of normal and underweight BMI, the USPSTF recommendation does not address frequency of screening. The recommendations from both the ADA and the AACE indicate screening at 3-year intervals for those who are eligible – for any reason. The supporting evidence review did not seem to address this aspect, and so it is understandable that there was no comment. However, I feel this will lead physicians to turn to the other guidelines for guidance where there is disagreement in other aspects.

Ultimately, the draft updated recommendation will provide physicians with the opportunity to identify more patients with prediabetes and DM. This will be wonderful in terms of being able to offer treatments and lifestyle interventions to decrease the morbidity patients would face were these conditions not diagnosed. I hope that future recommendations will also address risk factors in addition to BMI as well as frequency of screening for those who remain at increased risk but initially screen negative.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

1. Screening for prediabetes and type 2 diabetes mellitus. U.S. Preventive Services Task Force. 2021 Mar 16.

2. Classification and diagnosis of diabetes: Standards of medical care in diabetes – 2020. American Diabetes Association. Diabetes Care. 2020 Jan. doi: 10.2337/dc20-S002.

3. National Diabetes Statistics Report, 2020. Centers for Disease Control and Prevention.

4. American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan. Hadelsman Y et al. Endocr Pract. 2015 Apr. 1-87. doi: 10.4158/EP15672.GL.

The United States Preventive Services Task Force recently released a draft of updated recommendations for screening for prediabetes and type 2 diabetes mellitus (DM). If accepted as written, the new recommendation will be to “screen all asymptomatic adults ages 35 to 70 years who are overweight or obese.” Upon diagnosis of prediabetes, the recommendation is to offer or refer patients to preventive interventions.

This new recommendation would replace the one from 2015, which recommended screening adults aged 40-70 who are overweight or obese, lowering the age at which screening begins by 5 years. It would also replace the recommendation of referral to intensive behavioral counseling to promote a healthy diet and exercise.¹

The American Diabetes Association (ADA) identifies A1c, fasting plasma glucose, or oral glucose tolerance tests as appropriate tests for the diagnosis of prediabetes and type 2 DM, and the new draft recommendation does not provide a preference for method of screening.²

The USPSTF’s draft recommendation could expand screening with the hope of identifying patients with prediabetes, or those with diabetes who are asymptomatic, with the intent of beginning treatment before there are serious complications.
 

Unknown diabetes or prediabetes diagnosis common

It has been estimated by the Centers for Disease Control and Prevention that 12% of U.S. adults had DM as of 2015, though nearly 24% were not aware that they had it. Also, according to the CDC, the prevalence of DM increases with age and is higher in those with less than a high school education. The same report indicates that more than 30% of U.S. adults have prediabetes, and with less than 12% of those individuals are aware of it.³ A possible explanation for a patient’s being unaware of a diagnosis could be that it has been documented in a chart but the patient does not know such information is in his or her health record. According to the evidence provided for the updated recommendation, earlier diagnosis may have an important benefit in preventing serious complications.

A modeling study compared simulated screening strategies and found that the most optimal screening strategy from a cost-effectiveness perspective begins between the ages of 30 and 45, with rescreening every 3-5 years. Further models have led researchers to conclude that early diagnosis can lead to decreased cardiovascular events as well as an opportunity for multifactorial treatment.¹ For this reason, it makes sense to expand the ages of screening for obese and overweight individuals.
 

Treatment recommendations are more flexible

The change in treatment recommendations for a new diagnosis of prediabetes is potentially more useful. It may not be feasible or reasonable for physicians to always provide or refer their patients for intensive behavior interventions. The updated recommendation would allow for the inclusion of not only behavioral counseling and health education, but also potential medication options that are currently available but not approved, or that may be available in the future. The evidence review seemed to be mixed in outcome in this area, so the increased flexibility will likely allow for future opportunities.

Screening criteria may be too narrow

This recommendation, does not, however, provide any guidance on screening of individuals who have other risk factors besides a body mass index consistent with overweight or obesity. It seems that this may be a missed opportunity.

The draft statement clearly indicates that there are other factors associated with increased risk of developing DM, but does not consider these factors in determining which patients should be screened. Both the ADA and the American Association of Clinical Endocrinology (AACE) have recommendations for universal screening for all adults 45 and older, acknowledging that incidence of DM increases with age. The ADA also recommends screening individuals who are overweight or obese and have an additional risk factor regardless of age. The AACE recommends screening all individuals for risk factors regardless of age.

The current and draft recommendations by the USPSTF do not address other risk factors and indicate only that further research is needed to understand the risk associated with DM and the natural history of pre-DM and who may progress to DM or revert to normoglycemia. Without comment on other risk factors or universal screening with age, the USPSTF recommendation potentially would not be sensitive enough to capture all those who may meet criteria for prediabetes or DM.^2,4

In addition to not addressing other risk factors and screening for those of normal and underweight BMI, the USPSTF recommendation does not address frequency of screening. The recommendations from both the ADA and the AACE indicate screening at 3-year intervals for those who are eligible – for any reason. The supporting evidence review did not seem to address this aspect, and so it is understandable that there was no comment. However, I feel this will lead physicians to turn to the other guidelines for guidance where there is disagreement in other aspects.

Ultimately, the draft updated recommendation will provide physicians with the opportunity to identify more patients with prediabetes and DM. This will be wonderful in terms of being able to offer treatments and lifestyle interventions to decrease the morbidity patients would face were these conditions not diagnosed. I hope that future recommendations will also address risk factors in addition to BMI as well as frequency of screening for those who remain at increased risk but initially screen negative.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

1. Screening for prediabetes and type 2 diabetes mellitus. U.S. Preventive Services Task Force. 2021 Mar 16.

2. Classification and diagnosis of diabetes: Standards of medical care in diabetes – 2020. American Diabetes Association. Diabetes Care. 2020 Jan. doi: 10.2337/dc20-S002.

3. National Diabetes Statistics Report, 2020. Centers for Disease Control and Prevention.

4. American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan. Hadelsman Y et al. Endocr Pract. 2015 Apr. 1-87. doi: 10.4158/EP15672.GL.

Background: Guideline-directed medical therapy (use of beta-blockers, ACE inhibitor/angiotensin receptor blockers, and mineralocorticoid antagonists) provides clear benefits on mortality and morbidity in patients with HFrEF. Dapagliflozin (Farxiga) belongs to a class of sodium-glucose transporter 2 (SGLT2) inhibitors that inhibits reabsorption of sodium and glucose in the kidney and treats type 2 diabetes. This new class of drugs is emerging as an effective tool in the management of HFrEF based on the recent publication of the primary results of the DAPA-HF trial (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure). It demonstrated substantial benefits in terms of heart failure symptoms, hospitalizations, and mortality when added to triple therapy for patients with chronic HFrEF regardless of the presence of diabetes.

• Dapagliflozin showed a clinically significant benefit on health status (symptoms, physical function, and quality of life). Improved health-related quality of life (as measured by the well-validated Kansas City Cardiomyopathy Questionnaire score) with dapagliflozin in comparison with placebo was sustained for more than 8 months.
• Dapagliflozin reduced the risk of death and worsening heart failure and improved symptoms across the broad spectrum of ages studied in DAPA-HF. There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals.

Bottom line: Follow-up DAPA-HF studies further support the role of SGLT2 inhibitor dapagliflozin in improving mortality, reducing hospitalization, and improving the quality of life in patients with HFrEF and is considered a safe option across all age groups.

Citations: Kosiborod MN et al. Effects of dapagliflozin on symptoms, function, and quality of life in patients with heart failure and reduced ejection fraction: Results from the DAPA-HF trial. Circulation. 2020 Jan 14;141(2):90-9. Martinez FA et al. Efficacy and safety of dapagliflozin in heart failure with reduced ejection fraction according to age. Insights from DAPA-HF. Circulation. 2020 Jan 14;141:100-11.

Dr. Garg is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.

Background: Guideline-directed medical therapy (use of beta-blockers, ACE inhibitor/angiotensin receptor blockers, and mineralocorticoid antagonists) provides clear benefits on mortality and morbidity in patients with HFrEF. Dapagliflozin (Farxiga) belongs to a class of sodium-glucose transporter 2 (SGLT2) inhibitors that inhibits reabsorption of sodium and glucose in the kidney and treats type 2 diabetes. This new class of drugs is emerging as an effective tool in the management of HFrEF based on the recent publication of the primary results of the DAPA-HF trial (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure). It demonstrated substantial benefits in terms of heart failure symptoms, hospitalizations, and mortality when added to triple therapy for patients with chronic HFrEF regardless of the presence of diabetes.

• Dapagliflozin showed a clinically significant benefit on health status (symptoms, physical function, and quality of life). Improved health-related quality of life (as measured by the well-validated Kansas City Cardiomyopathy Questionnaire score) with dapagliflozin in comparison with placebo was sustained for more than 8 months.
• Dapagliflozin reduced the risk of death and worsening heart failure and improved symptoms across the broad spectrum of ages studied in DAPA-HF. There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals.

Bottom line: Follow-up DAPA-HF studies further support the role of SGLT2 inhibitor dapagliflozin in improving mortality, reducing hospitalization, and improving the quality of life in patients with HFrEF and is considered a safe option across all age groups.

Citations: Kosiborod MN et al. Effects of dapagliflozin on symptoms, function, and quality of life in patients with heart failure and reduced ejection fraction: Results from the DAPA-HF trial. Circulation. 2020 Jan 14;141(2):90-9. Martinez FA et al. Efficacy and safety of dapagliflozin in heart failure with reduced ejection fraction according to age. Insights from DAPA-HF. Circulation. 2020 Jan 14;141:100-11.

Dr. Garg is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.

Background: Guideline-directed medical therapy (use of beta-blockers, ACE inhibitor/angiotensin receptor blockers, and mineralocorticoid antagonists) provides clear benefits on mortality and morbidity in patients with HFrEF. Dapagliflozin (Farxiga) belongs to a class of sodium-glucose transporter 2 (SGLT2) inhibitors that inhibits reabsorption of sodium and glucose in the kidney and treats type 2 diabetes. This new class of drugs is emerging as an effective tool in the management of HFrEF based on the recent publication of the primary results of the DAPA-HF trial (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure). It demonstrated substantial benefits in terms of heart failure symptoms, hospitalizations, and mortality when added to triple therapy for patients with chronic HFrEF regardless of the presence of diabetes.

• Dapagliflozin showed a clinically significant benefit on health status (symptoms, physical function, and quality of life). Improved health-related quality of life (as measured by the well-validated Kansas City Cardiomyopathy Questionnaire score) with dapagliflozin in comparison with placebo was sustained for more than 8 months.
• Dapagliflozin reduced the risk of death and worsening heart failure and improved symptoms across the broad spectrum of ages studied in DAPA-HF. There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals.

Bottom line: Follow-up DAPA-HF studies further support the role of SGLT2 inhibitor dapagliflozin in improving mortality, reducing hospitalization, and improving the quality of life in patients with HFrEF and is considered a safe option across all age groups.

Citations: Kosiborod MN et al. Effects of dapagliflozin on symptoms, function, and quality of life in patients with heart failure and reduced ejection fraction: Results from the DAPA-HF trial. Circulation. 2020 Jan 14;141(2):90-9. Martinez FA et al. Efficacy and safety of dapagliflozin in heart failure with reduced ejection fraction according to age. Insights from DAPA-HF. Circulation. 2020 Jan 14;141:100-11.

Dr. Garg is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.