Acute myocarditis following a third dose of COVID-19 mRNA vaccination in adults.

INTRODUCTION: Myocarditis has been reported following the second dose of COVID-19 mRNA vaccination. Whether administration of additional doses of COVID-19 vaccines further increases the risk of myocarditis is unknown. METHODS: We included individuals who received one to three doses of BNT162b2 or mRNA-1273 mRNA vaccine between 12/14/2020 and 2/18/2022. Myocarditis within 21 days of vaccine administration was identified using electronic medical records. Incidence rate ratios were calculated by comparing the observed incidence with the expected incidence from the same population during a 365-day baseline period. RESULTS: Of 3,076,660 KPSC members who received at least one dose of COVID-19 mRNA vaccines, 2,916,739 (94.5%) received at least two doses, and 1,146,254 (47.0%) received three doses. The incidence rate ratio for myocarditis was 0.86 (95% CI 0.31-1.93) for the first dose, 4.22 (95% CI 2.63-6.53) for the second dose, and 2.61 (1.13-5.29) for the third dose. Most myocarditis cases following the second and third dose occurred within seven days of vaccination. CONCLUSION: Myocarditis was a rare event observed after the second or third dose of vaccination. Most cases presented within seven days of vaccination. The incidence of myocarditis following the third dose was not significantly higher than that observed after the second dose.

Cardiogenic Shock and Respiratory Failure Complicating Takotsubo Syndrome.

OBJECTIVES: This study's purpose is to evaluate the incidence, predictors, and outcomes of patients presenting to the cardiac catheterization laboratory with takotsubo syndrome complicated by respiratory failure or shock. BACKGROUND: The presentation of takotsubo syndrome mimics acute myocardial infarction. It is often diagnosed in the cardiac catheterization laboratory when no coronary obstruction is found. A subset of these patients develops shock or respiratory failure. METHODS: This is a retrospective study of patients who underwent cardiac catheterization at the Kaiser Permanente Southern California health system with takotsubo syndrome between 2006 to 2016. Medical records were manually reviewed to identify patient characteristics, treatment, and clinical outcomes. RESULTS: Among 530 patients with takotsubo syndrome, 56 (10.6%) developed shock or respiratory failure and required mechanical or inotropic support. A higher proportion of these patients were men (14.3% vs 5.7%) and Black (10.7% vs 7.0%). In multivariate logistic regression analyses, factors associated with respiratory failure or shock were age (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.94-0.99; P=.02), chronic obstructive pulmonary disease (OR, 1.9; 95% CI, 1.1-3.5; P=.02), chronic kidney disease (OR, 2.6; 95% CI, 1.3-5.3; P=.01), physical trigger (OR, 5.7; 95% CI, 3.0-10.8; P<.01), and ST elevation on the presenting electrocardiogram (OR, 2.5; 95% CI, 1.4-4.8; P=.04). Patients who required mechanical ventilation or inotropic support had significantly higher mortality (hazard ratio, 3.9; 95% CI, 2.1-7.1; P<.001). CONCLUSION: Shock or respiratory failure occur in 10.6% of patients presenting with takotsubo syndrome. Men and patients with baseline respiratory or renal disease were disproportionally affected. These patients have significantly worse clinical outcomes.

Clinical Characteristics and Outcomes of Patients With Takotsubo Syndrome.

BACKGROUND: Characteristics and outcomes of patients with takotsubo syndrome remain to be defined. The goal of this study was to report the characteristics and long-term outcomes of patients presenting with takotsubo syndrome compared with other patients presenting with acute myocardial infarction (AMI) in a community-based population. METHODS: This retrospective population-based study included patients hospitalised for AMI from 2006 to 2016. Those patients with takotsubo syndrome were compared with the patients with AMI. The primary outcome was all-cause mortality. Matching was performed to assemble a cohort of patients with similar baseline characteristics. RESULTS: Among 26,015 patients hospitalised with an initial diagnosis of AMI, 530 (2.0%) were diagnosed with takotsubo syndrome. Patients with takotsubo syndrome were older (68.3 ± 11.3 vs 65.6 ± 12.2 years) and more likely to be women (93.4% vs 30.7%). Concomitant hypothyroidism, rheumatologic disorders, and lung disease were more prevalent in the takotsubo syndrome group, whereas diabetes and hyperlipidemia were less prevalent. Mortality was lower in the takotsubo syndrome group (1-year mortality 4.0% vs 8.9%; P < 0.001). The 530 patients with takotsubo syndrome were matched with 1,315 AMI patients with similar baseline characteristics. At a follow-up of 5.4 ± 3.3 years, patients with takotsubo syndrome had a lower risk for all-cause death than other patients who presented with AMI (hazard ratio 0.59, 95% CI 0.47-0.76). CONCLUSIONS: Among patients presenting with AMI, patients with takotsubo syndrome were older and more likely to be women. Patients with takotsubo syndrome had better long-term outcomes compared with matched AMI patients.

Survival and risk of recurrence of takotsubo syndrome.

OBJECTIVE: The goal of this study is to evaluate the long-term outcomes of patients with takotsubo syndrome and assess factors associated with death or recurrence. METHODS: This is a retrospective population-based cohort study of consecutive patients who presented to an integrated health system in Southern California with takotsubo syndrome between 2006 and 2016. Medical records were manually reviewed to confirm diagnosis and to identify predisposing factors, medication treatment and long-term outcomes. Factors associated with death or recurrent takotsubo syndrome were tested using Cox regression models. RESULTS: Between 2006 and 2016, there were 519 patients with a confirmed diagnosis of takotsubo syndrome. Patients were followed for 5.2 years (IQR 3.0-7.2). During the follow-up period, 39 (7.5%) had recurrent takotsubo syndrome and 84 (16.2%) died. In multivariate modelling, factors associated with higher risk of recurrence or death were age (HR 1.56 per 10-year increase, 95% CI 1.29 to 1.87), male sex (HR 2.52, 95% CI 1.38 to 4.60), diabetes (HR 1.6, 95% CI 1.06 to 2.43), pulmonary disease (HR 2.0, 95% CI 1.37 to 2.91) and chronic kidney disease (HR 1.58, 95% CI 1.01 to 2.47). Treatment with beta-blockers were associated with lower risk of recurrence or death (HR 0.46, 95% CI 0.29 to 0.72). No association was observed between treatment with ACE inhibitors or angiotensin-receptor blockers and recurrence or death (HR 0.92, 95% CI 0.59 to 1.42). CONCLUSIONS: Recurrent takotsubo syndrome occurred in a minor subset of patients. Treatment with beta-blocker was associated with higher event-free survival.

Contribution of Cardiac Implantable Electronic Devices to Thrombus Formation in Patients With Chronic Thromboembolic Pulmonary Hypertension.

OBJECTIVES: This study aimed to identify the prevalence of cardiac implantable electronic devices (CIEDs) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and to describe the associated disease burden. BACKGROUND: CTEPH is a debilitating disease, now potentially curable with pulmonary thromboendarterectomy (PTE). The contribution of CIEDs to thrombosis in this patient population has not been previously studied. METHODS: The charts of 982 CTEPH patients, who underwent PTE between January 1, 2009, and December 31, 2015 at University of California-San Diego (UCSD) Medical Center, were reviewed for pacemakers or implantable cardioverter defibrillators (ICDs) implanted before surgery. RESULTS: Among 982 CTEPH patients who underwent PTE, 14 had pacemakers and 3 had ICDs, giving 17 CIEDs and a prevalence of 1.7%. Of these 17 CIEDs, 6 devices were extracted intraoperatively, and 5 of 6 devices were replaced with epicardial leads. Furthermore, of the 950 patients classified by intraoperative UCSD level, 12 of 17 (70.6%) patients with CIEDs had distal disease versus 241 of 933 (25.8%) patients without CIEDs (p = 0.0002). The prevalence of known venous thromboembolism (VTE) was 50% in CIED patients compared with 78.6% in patients without CIEDs (p = 0.018). CONCLUSIONS: At 1.7%, the prevalence of CIEDs in the PTE population was higher than previously reported values, which estimated CIED prevalence between 0.16% and 0.47% in the general population. Moreover, CTEPH patients with CIEDs were more strongly associated with distal disease burden and less likely to have had previous VTE, which suggested that CIEDs may be a nidus for small clots that embolize distally in the pulmonary vasculature.

Qualitative Methods in the Development of a Bilingual and Bicultural Quality of Life Outcomes Measure for Pediatric Patients With Craniofacial Conditions.

INTRODUCTION: Craniofacial surgeons treat patients with diverse craniofacial conditions (CFCs). Yet, little is known about the health-related quality of life (HRQoL) impact of diverse CFCs. Currently, there are no suitable instruments that measure the HRQoL of patients with diverse CFCs from the perspective of children and parents. The objective of this study was to develop the items and support the content validity of a comprehensive patient and parent-reported outcomes measure. METHODS: An iterative process consisting of a systematic literature review, expert opinion and in-depth interviews with patients and parents of patients with diverse CFCs was used. The literature review and expert opinion were used to generate in-depth interview questions. We interviewed 127 subjects: 80 parents of patients ages 0 to 18 years or older and 47 patients ages 7 to 18 years or older. English and Spanish speakers were represented in our sample. The majority of subjects originated from the United States and Mexico (83%). Craniofacial conditions included were cleft lip/palate, craniosynostosis, craniofacial microsomia, microtia, and dermatological conditions. Semistructured interviews were conducted until content saturation was achieved. Line-by-line analysis of interview transcripts identified HRQoL themes. Themes were interpreted and organized into larger domains that represent the conceptual framework of CFC-associated HRQoL. Themes were operationalized into items that represent the HRQoL issues of patients for both parent and patient versions. RESULTS: Six final bilingual and bicultural scales based on the domains derived from the literature review, expert opinion, and in-depth interviews were developed: (1) "Social Impact," (2) "Psychological Function," (3) "Physical Function," (4) "Family Impact," (5) "Appearance," And (6) "Finding Meaning." Some cultural differences were identified: in contrast to children from Mexico and other developing nations, families from the United States did not report public harassment or extremely negative public reactions to patients' CFC. Religion and spirituality were common themes in interviews of Spanish-speaking subjects but less common in interviews of English-speaking subjects. CONCLUSIONS: Qualitative methods involving pediatric patients with diverse CFCs and their parents in the item development process support the content validity for this bilingual and bicultural HRQoL instrument. The items developed in this study will now undergo psychometric testing in national multisite studies for validation.

Outside slide review in gynecologic oncology: impact on patient care and treatment.

In gynecologic oncology, surgical and adjuvant therapy rely heavily on correct pathologic diagnosis. Thus, in-house review of outside pathologic slides and specimens has become routine within large tertiary referral centers. We sought to determine the impact of outside pathologic slide review on gynecologic oncology patient care and treatment. Gynecologic oncology cases between January 2007 and January 2012 were evaluated. Clinical information was gathered from comprehensive chart reviews and reports created after multidisciplinary treatment planning conferences. Discrepancies in diagnosis were identified as major if they resulted in a treatment alteration and minor if they did not impact care. Data were analyzed using descriptive statistics and the Fisher exact test. A total of 279 cases were identified and reviewed as part of the study--126 (45.2%) biopsy/cytology specimens and 153 (54.8%) surgical excision specimens. Minor discrepancies were noted in 25 reviewed cases (9%) and major discrepancies in 19 cases (6.8%). Among those patients in whom management was changed based on specialized pathologic review, 50% underwent additional surgery, 16% had their surgical plan modified, and 16% received adjuvant treatment or had their adjuvant treatment modified. In 235 cases (84.2%), institutional rereview of the outside slides/specimens did not result in a change in diagnosis. Diagnostic discrepancies were evenly distributed across all primary sites evaluated. The cost of outside pathologic review was estimated at $2,936 US dollars per change in diagnosis. Mandatory slide review in gynecologic oncology is important and results in diagnostic changes in approximately 16% of cases, with 43% of those changes impacting treatment.

ATL 313, A Selective A(2A) Adenosine Receptor Agonist, Reduces Myocardial Infarct Size in a Rat Ischemia/Reperfusion Model.

OBJECTIVE: The cardioprotective effects of activation of the A(2A) adenosine receptor (A(2A)AR) on ischemia/reperfusion injury in the heart remain controversial. We investigated whether ATL 313, a new selective A(2A)AR agonist, could reduce myocardial infarct size in a rat ischemia/reperfusion model. METHODS: Sprague-Dawley rats were subjected to a 40 minute occlusion of the left coronary artery followed by 3 hours reperfusion. Hemodynamics were monitored during the procedure. The rats were divided into 3 groups: Group 1 received continuous intravenous infusion of saline given 10 min prior to ischemia and throughout reperfusion (n=8); Group 2 received continuous intravenous infusion of 10 ng/kg/min of ATL 313 given 10 min prior to ischemia, and throughout reperfusion (n=8); and group 3 received an intravenous bolus of ATL 313 (900 ng/Kg body weight) given 10 min prior to ischemia, and continuous intravenous infusion of 10 ng/kg/min of ATL 313 started at 20 min after ischemia and throughout reperfusion (n=8). After euthanasia of the rats, the hearts were harvested for the assessment of risk zone and zone of necrosis of the left ventricle. RESULTS: The percentage of risk zone in the left ventricle was similar among group 1 (47 +/- 3.7 %), group 2 (41.5 +/- 4.2 %) and group 3 (42.4 +/- 3.8 %). However, the infarct size, expressed as a percentage of the risk zone, was significantly decreased in group 3 (30.6 +/- 5 %, P=0.01) compared with group 1 (53.8 +/- 6.2 %) and group 2 (52.1 +/- 4.8 %). In group 3, the bolus injection of ATL 313 caused a reduction in blood pressure during the procedure, and decreased heart rate and LV +/-dp/dt before coronary artery occlusion; but increased LV +dp/dt at the end of reperfusion compared to the other 2 groups. CONCLUSION: A(2A)AR agonist ATL313 significantly reduced infarct size and improved LV contractility at the end of reperfusion assessed by LV dp/dt at a dose of 900 ng/Kg. The mechanisms for the observed cardioprotection effect of ATL313 remain to be determined.