Incidence Rates and Clinical Characteristics of Patients With Confirmed Myocarditis or Pericarditis Following COVID-19 mRNA Vaccination: Experience of the Veterans Health Administration Through 9 October 2022.

Background: Although the benefits outweigh the risks, COVID-19 vaccines have been associated with an increased risk of myocarditis and pericarditis. This report is based on a national US veteran population with confirmed myocarditis/pericarditis following mRNA COVID-19 vaccines according to the near real-time active surveillance program of Veterans Affairs. Methods: This study is based on a cohort evaluation of all adults administered ≥1 mRNA COVID-19 vaccine, including boosters, in the Veterans Health Administration between 14 December 2020 and 9 October 2022. ICD-10-CM diagnosis codes were used to identify potential safety signals in near real time through a database analysis. All potential cases of myocarditis/pericarditis identified in the database analysis underwent in-depth chart review and case validation by a team of pharmacists and expert clinicians. Our main outcome was the incidence rate of confirmed myocarditis/pericarditis among vaccine recipients (overall and those aged 18-39 years) within 21 days of a first, second, or booster dose of a mRNA COVID-19 vaccine. We calculated the ratio of observed events among COVID-19 vaccine recipients over expected events from historical vaccine recipient controls (2015-2020) in the Veterans Health Administration. We used confirmed cases to calculate incidence rates and 95% CIs. Results: Through 9 October 2022, 3 877 453 doses of BNT162b2 (Pfizer-BioNTech) and 4 221 397 doses of mRNA-1273 (Moderna) were administered as first or second dose across Veterans Affairs, and 1 012 561 BNT162b2 and 1 156 160 mRNA-1273 booster doses were administered. Among all doses, the rapid cycle analysis identified 178 potential cases of myocarditis/pericarditis among vaccinees of any age and 22 potential cases among those aged 18-39 years. Of these, 33 cases, including 6 among those 18-39 years old, were confirmed after in-depth chart review and validation, corresponding with an overall incidence rate per million ranging from 0.46 (95% CI, .01-2.55) for Moderna dose 1 to 6.91 (95% CI, 2.78-14.24) for Pfizer booster. Among those aged 18-39, incidence rates ranged from 7.1 (95% CI, .18-39.56) for Moderna dose 2 to 19.76 (95% CI, 5.38-50.58) for Pfizer dose 2. Patients with confirmed cases were hospitalized for a mean 4.1 days (range, 1-15). The final disposition for 32 (97%) of 33 cases was discharge to home. Conclusions: This report is a real-world demonstration of the Veterans Affairs' active surveillance system for vaccines. Although the rapid cycle analysis initially identified 178 potential cases of myocarditis/pericarditis, only 1 of 5 cases was confirmed to be related to a COVID-19 vaccine after chart review. These findings highlight the paramount importance of active surveillance and chart validation for rare but serious adverse events related to COVID-19 vaccines.

Comparison of clinical pharmacy specialists and usual care in outpatient management of hyperglycemia in Veterans Affairs medical centers.

PURPOSE: The results of a study to assess the effectiveness and safety of hyperglycemia management provided by clinical pharmacy specialists (CPSs) versus usual care in outpatients with diabetes from 53 Veterans Affairs (VA) medical centers are reported. METHODS: An historical cohort study of outpatients with baseline glycosylated hemoglobin (HbA1c) values of >9% who were referred to a CPS for management of hyperglycemia and primary care patients who were not referred to a CPS was conducted. The primary outcomes were change in HbA1c over time and time to reach an HbA1c value of <8%. Secondary outcomes included the number of visits to achieve an HbA1c value of <8%, proportion of patients with an HbA1c value of <6% who were receiving secretagogues, and proportion of patients with serious hypoglycemia. RESULTS: After propensity score matching by baseline characteristics, there were 12,327 patients in each group. The mean ± S.D. number of visits to reach an HbA1c value of <8% was 2.46 ± 1.58 in the pharmacist-managed group and 1.82 ± 1.27 with usual care (p < 0.001). The proportion of patients with an HbA1c value of <6% who were receiving secretagogues was 39.9% with pharmacist-managed care and 38.6% with usual care (p = 0.73). Serious hypoglycemia was noted in 4.3% of pharmacist-managed patients and 3.1% of usual care patients (p < 0.001). CONCLUSION: Data from 53 VA medical centers revealed that CPSs managed the care of ambulatory care patients with hyperglycemia as well as primary care providers.

Computer-aided design/computer-aided manufacturing skull base drill.

The authors have developed a simple device for computer-aided design/computer-aided manufacturing (CAD-CAM) that uses an image-guided system to define a cutting tool path that is shared with a surgical machining system for drilling bone. Information from 2D images (obtained via CT and MRI) is transmitted to a processor that produces a 3D image. The processor generates code defining an optimized cutting tool path, which is sent to a surgical machining system that can drill the desired portion of bone. This tool has applications for bone removal in both cranial and spine neurosurgical approaches. Such applications have the potential to reduce surgical time and associated complications such as infection or blood loss. The device enables rapid removal of bone within 1 mm of vital structures. The validity of such a machining tool is exemplified in the rapid (< 3 minutes machining time) and accurate removal of bone for transtemporal (for example, translabyrinthine) approaches.

Breast cancer surgery trends and outcomes: results from a National Department of Veterans Affairs study.

BACKGROUND: This study examined trends and outcomes for breast cancer surgery performed at Department of Veterans Affairs (VA) hospitals. STUDY DESIGN: We examined breast cancer operations performed in VA hospitals from October 1991 to September 1997. Data from the VA National Surgical Quality Improvement Program, surgical pathology reports, discharge data, and outpatient data were used. Surgical outcomes included postoperative length of stay, 30-day morbidity rates, 1-year surgery-related readmission rates, and mortality. An expert panel of breast cancer clinicians identified surgery-related hospital readmissions. Hierarchical regression analysis was used to identify patient, provider, and hospital characteristics associated with postoperative length of stay, and 30-day morbidity. RESULTS: From October 1991 to September 1997 1,333 breast operations were performed, ranging from 1 to 38 on average per hospital; 478 operations were for breast cancer. Among breast cancer surgery patients, 25% were men. Thirty-day morbidity rates, 1-year hospital readmission rates, and mortality were very low for both men and women. Postoperative length of stay averaged 6.8 days. Lower income, longer operation times, and older age increased the likelihood of 30-day morbidity. Lower functional status, older age, longer operation time, and lower average annual volume of procedures increased postoperative length of stay. Documentation of the extent of disease and surgical margin in pathology reports was poor in medical records. CONCLUSIONS: Hospital stays were longer, and morbidity and readmission rates for patients having breast cancer operations at VA hospitals were comparable to those reported for private sector hospitals.