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1.
Clin Rheumatol ; 41(5): 1597-1601, 2022 May.
Article in English | MEDLINE | ID: mdl-35294664

ABSTRACT

The Pfizer-BioNTech COVID-19 vaccine has been authorized by the U.S. Food and Drug Administration as it demonstrated 95% effectiveness against the SARS-CoV-2 virus. Although the initial vaccine trials showed a favorable side effect profile, there have been concerns regarding activation of aberrant immune responses, triggering autoimmunity. This is a case report of a 68-year-old woman without history of autoimmune conditions, who presented to our emergency department 7 days after receiving the Pfizer-BioNTech COVID-19 vaccine. Her initial symptoms were suggestive of polymyalgia rheumatica, and she had nearly complete response to steroids. Interestingly, she later met criteria for classified systemic lupus erythematous given the development of inflammatory arthritis, positive ANA, and positive dsDNA. The temporal relationship of her symptoms that started 2 days after vaccine administration could suggest a possible association between the Pfizer-BioNTech COVID-19 and the development of systemic lupus erythematous.


Subject(s)
COVID-19 Vaccines , COVID-19 , Aged , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Humans , SARS-CoV-2 , United States , United States Food and Drug Administration
2.
J Cardiovasc Pharmacol ; 75(4): 299-304, 2020 04.
Article in English | MEDLINE | ID: mdl-31934912

ABSTRACT

Parenteral prostacyclin therapies remain first-line therapy for patients with pulmonary arterial hypertension (PAH) with class IV symptoms. In selected patients who have been clinically stabilized, switching to selexipag, a chemically distinct prostacyclin receptor agonist, may alleviate risks associated with long-term parenteral therapy. We report our experience with transition of patients from parenteral prostacyclin therapy to selexipag. From January 2016 to July 2017, patients with PAH at the Duke University Pulmonary Vascular Disease Center with functional class II symptoms on stable parenteral prostacyclin therapy were offered the opportunity to transition to selexipag. A standardized protocol was developed to guide titration of therapies. Patients underwent pre- and post-transition assessments of hemodynamics, echocardiography, laboratory biomarkers, and functional status. We studied 14 patients with PAH (11 women; median age 53 years) in total. Overall, 13 patients tolerated the switch to selexipag and remained on the drug at study completion, and 1 patient passed away due to progressive liver failure. Surrogate markers including NT-proBNP, 6MWD, RV function, and TAPSE, and right heart catheterization hemodynamics were similar before and after transition. The transition from parenteral prostanoid therapy to oral selexipag was overall well-tolerated in patients with stable PAH and functional class II symptoms. Finally, doses of selexipag up to 3200 µg twice daily were well-tolerated in patients who had been treated with prior parenteral prostacyclins.


Subject(s)
Acetamides/administration & dosage , Antihypertensive Agents/administration & dosage , Arterial Pressure/drug effects , Drug Substitution , Prostaglandins I/administration & dosage , Pulmonary Arterial Hypertension/drug therapy , Pulmonary Artery/drug effects , Pyrazines/administration & dosage , Acetamides/adverse effects , Antihypertensive Agents/adverse effects , Feasibility Studies , Female , Humans , Infusions, Parenteral , Male , Middle Aged , Prospective Studies , Prostaglandins I/adverse effects , Pulmonary Arterial Hypertension/diagnosis , Pulmonary Arterial Hypertension/physiopathology , Pulmonary Artery/physiopathology , Pyrazines/adverse effects , Receptors, Epoprostenol/agonists , Time Factors , Treatment Outcome
3.
World Neurosurg ; 114: e483-e494, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29574224

ABSTRACT

INTRODUCTION: Secondary cerebral insults can adversely affect patients with traumatic brain injury. By contrast, the incidence of secondary cerebral insults after aneurysmal subarachnoid hemorrhage (SAH) and their impact on outcome have been less well studied. METHODS: Four hundred and twenty-one patients with SAH who underwent surgical occlusion of their ruptured aneurysm and who received intensive care unit care for ≥48 hours were retrospectively identified from a prospective observational database. Patients were managed according to standard recommendations for SAH. Three secondary cerebral insults were examined: hypotension (<90 mmHg systolic), hypoxia (Pao2 <60 mm Hg), and hyperglycemia (>200 mg/dL). RESULTS: A secondary cerebral insult was observed in 309 (73.4%) patients including 135 (32.1%) who had multiple insults. There was an association between worse clinical grade and development of secondary insults (P = 0.0002), particularly multiple insults (P < 0.0001). When stratified by clinical grade, single (adjusted odds ratio [OR], 2.23; 95% confidence interval [CI], 1.10-4.51; P = 0.026) and multiple (adjusted OR, 4.37; 95% CI, 2.14-8.93; P < 0.0001) secondary cerebral insults were associated with worse outcome. In multivariate analysis and controlling for age, admission clinical grade, severity of SAH on computed tomography, intracerebral hematoma, increased intracranial pressure (>20 mm Hg), rebleed, intraoperative rupture, and hydrocephalus, secondary cerebral insults were independently associated with poor outcome (adjusted OR, 2.45; 95% CI, 1.20-5.02; P = 0.014). CONCLUSIONS: Secondary cerebral insults (hypoxia, hypotension, and hyperglycemia) are common after SAH, including among patients with a good clinical grade. These insults after SAH are associated with worse outcome. These data suggest that prevention of secondary cerebral insults may provide an opportunity to improve patient outcome after SAH.


Subject(s)
Intracranial Aneurysm/complications , Intracranial Aneurysm/epidemiology , Subarachnoid Hemorrhage/epidemiology , Subarachnoid Hemorrhage/etiology , Vasospasm, Intracranial/etiology , Aged , Female , Glasgow Coma Scale , Humans , Hyperglycemia/etiology , Hypotension/etiology , Hypoxia/etiology , Incidence , Intracranial Aneurysm/surgery , Logistic Models , Male , Middle Aged , Severity of Illness Index , Subarachnoid Hemorrhage/surgery , Vasospasm, Intracranial/epidemiology
4.
World Neurosurg ; 108: 807-816, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29038077

ABSTRACT

BACKGROUND: The optimal red blood cell transfusion (RBCT) trigger for patients with aneurysmal subarachnoid hemorrhage (SAH) is unknown. In patients with cerebral vasospasm, anemia may increase susceptibility to ischemic injury; conversely, RBCT may worsen outcome given known deleterious effects. OBJECTIVE: To examine the association between RBCT, delayed cerebral ischemia (DCI), vasospasm, and outcome after SAH. METHODS: A total of 421 consecutive patients with SAH, admitted to a neurocritical care unit at a university-affiliated hospital and who underwent surgical occlusion of their ruptured aneurysm were retrospectively identified from a prospective observational database. Propensity score methods were used to reduce the bias associated with treatment selection. RESULTS: Two hundred and sixty-one patients (62.0%) received an RBCT. Angiographic vasospasm (odds ratio [OR] 1.6; 95% confidence interval [CI], 1.1-2.3; P = 0.025) but not severe angiographic spasm, DCI, or delayed infarction was associated with RBCT. A total of 283 patients (67.2%) experienced a favorable outcome, defined as good or moderately disabled on the Glasgow Outcome Scale; 47 (11.2%) were severely disabled or vegetative and 91 patients (21.6%) were dead at 6-month follow-up. Among patients who survived ≥2 days, RBCT was associated with unfavorable outcome (OR, 2.6; 95% CI, 1.6-4.1). Transfusion of ≥3 units of blood was associated with an increased incidence of unfavorable outcome. Propensity analysis to control for the probability of exposure to RBCT conditional on observed covariates measured before RBCT indicates that RBCT is associated with unfavorable outcome in the absence of DCI (OR, 2.17; 95% CI, 1.56-3.01; P < 0.0001) but not when DCI is present (OR, 0.82; 95% CI, 0.35-1.92; P = 0.65). CONCLUSIONS: Blood transfusions are associated with unfavorable outcome after SAH particularly when DCI is absent. Propensity analysis suggests that RBCT may be associated with poor outcome rather than being a marker of disease severity. However, when DCI is present, RBCT may help improve outcome.


Subject(s)
Anemia/therapy , Aneurysm, Ruptured/surgery , Cerebral Infarction/epidemiology , Erythrocyte Transfusion/statistics & numerical data , Intracranial Aneurysm/surgery , Subarachnoid Hemorrhage/surgery , Vasospasm, Intracranial/epidemiology , Adult , Aged , Anemia/complications , Aneurysm, Ruptured/complications , Brain Ischemia/epidemiology , Cerebral Angiography , Databases, Factual , Female , Glasgow Outcome Scale , Humans , Incidence , Intracranial Aneurysm/complications , Male , Middle Aged , Neurosurgical Procedures , Odds Ratio , Retrospective Studies , Subarachnoid Hemorrhage/etiology , Treatment Outcome
5.
Oral Oncol ; 66: 9-13, 2017 03.
Article in English | MEDLINE | ID: mdl-28249654

ABSTRACT

IMPORTANCE: Management of cervical unknown primary squamous cell carcinoma (CUP) has evolved with the introduction of transoral robotic surgery (TORS). OBJECTIVES: 1. To describe the efficacy of TORS lingual and palatine tonsillectomy in identifying the primary site of malignancy. 2. To explore how the extent of surgery affects diagnostic yield. 3. To report margin status of TORS resections. DESIGN, SETTING AND PARTICIPANTS: A retrospective, single-center cohort study utilizing a prospectively collected database of CUP patients in a high-volume tertiary referral center. Patient underwent operative laryngoscopy plus TORS as clinically indicated. MAIN OUTCOMES AND MEASURES: Primary end point was successful identification of the primary. The extent of surgery and margin status were also examined. RESULTS: From 2010-2016, 64 patients with CUP were treated. The primary tumor was found in 51 patients (80%). Fourteen patients (22%) were identified with operative laryngoscopy alone. Fifty patients underwent TORS lingual tonsillectomy ± palatine tonsillectomy with 37 primary tumors identified (74%). The primary was located in the lingual tonsil in 32 patients (86%) and palatine tonsil in 5 patients (10%, p<0.001). Negative margins were achieved in 19 patients (51%). The deep margin was the most commonly positive margin (47%, p=0.049). CONCLUSION AND RELEVANCE: Operative laryngoscopy with TORS is efficacious, localizing the primary in 80% of patients. If a margin was positive, it was most commonly the deep margin. This study provides valuable information that can help standardize surgical technique, further increasing the diagnostic yield and decreasing the negative margin rate of TORS for CUP.


Subject(s)
Carcinoma, Squamous Cell/surgery , Head and Neck Neoplasms/surgery , Neck , Robotic Surgical Procedures , Aged , Female , Humans , Male , Middle Aged , Squamous Cell Carcinoma of Head and Neck , Treatment Outcome
6.
World Neurosurg ; 97: 132-139, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27641256

ABSTRACT

BACKGROUND: Jehovah's Witnesses (JW) are a Christian faith with >1 million members in the United States who do not accept autologous blood transfusions. The optimal management of these patients undergoing neurosurgical procedures is not well defined. Here, we examined the feasibility and safety of JW undergoing neurosurgery in a blood management program. STUDY DESIGN AND METHODS: Sixty-eight JW patients including 23 men and 45 women (mean age 53 ± 12 years) who underwent a variety of cranial (n = 19) and spinal (n = 49) neurosurgical procedures during a 5-year period were identified retrospectively and their hospital charts, anesthetic records, and operative reports reviewed. A concurrent cohort of sex-, age-, and procedure-matched non-JW controls also was identified. RESULTS: Among JW patients, a cell-saving system was used in 27 cases, with blood retransfused in 13 cases. Lactated Ringers solution was used extensively intraoperatively; albumin was given to 15 patients. The median decrease in hemoglobin was 2.1 g/dL. One patient had a postoperative hemoglobin value <7 g/dL. One patient returned to the operating room to revise a lumbar pedicle screw, and one patient had postoperative seizures. No cardiopulmonary complications, sepsis, pneumonia, or wound infection were observed. Compared with the matched control group, similar outcome results were observed. Blood loss and operative time also were similar in JW patients and controls. CONCLUSIONS: Neurosurgical procedures in Jehovah's Witnesses are feasible, safe, and have similar outcomes to patients willing to accept transfusion when managed within a multidisciplinary blood-management program.


Subject(s)
Blood Transfusion/methods , Brain Diseases/surgery , Jehovah's Witnesses , Neurosurgical Procedures/methods , Spinal Cord Diseases/surgery , Adult , Aged , Blood Loss, Surgical/prevention & control , Case-Control Studies , Female , Follow-Up Studies , Hemoglobins/therapeutic use , Humans , Jehovah's Witnesses/psychology , Male , Middle Aged , Retrospective Studies
7.
World Neurosurg ; 96: 215-221, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27072337

ABSTRACT

OBJECTIVE: Hypercoagulability after subarachnoid hemorrhage (SAH) is well described and may be platelet mediated. Thromboelastography (TEG) provides a global assessment of coagulation. We sought to determine whether the maximum amplitude (MA) parameter of TEG, a measure of platelet strength and function, is associated with outcome after SAH. METHODS: One hundred ten TEG analyses were performed for patients with moderate-to-severe SAH and compared with 6 healthy age- and sex-matched controls. TEG indices included MA, G value (G), alpha angle, and thrombus generation and were correlated to functional outcomes and laboratory tests including complete blood count, erythrocyte sedimentation rate, high sensitivity C-reactive protein, fibrinogen, and d-dimer, obtained on post-bleed days (PBDs) 1, 3, 5, 7, and 10. RESULTS: MA was significantly elevated compared with controls on PBD 3 (70.0 mm ± 4.5 mm vs. 64.1 mm ± 6.5 mm; P = 0.02), PBD 5 (72.6 mm ± 5.3 mm vs. 64.1 mm ± 6.5 mm; P = 0.003), PBD 7 (73.0 mm ± 5.4 mm vs. 64.1 mm ± 6.5 mm; P = 0.003), and PBD 10 (73.4 mm ± 6.0 mm vs. 64.1 mm ± 6.5 mm; P = 0.005). G was significantly elevated compared with controls on PBD 3 (P = 0.03), PBD 5 (P = 0.01), PBD 7 (P = 0.01), and PBD 10 (P = 0.02). The only biomarker associated with poor outcome was CRP. Multivariate logistic regression demonstrated an association between elevated MA and outcome (odds ratio 39.1, P = 0.006) independent of CRP, age, Hunt Hess grade, and transfusion. CONCLUSIONS: TEG indices are associated with poor outcome after SAH and may identify a platelet-mediated hypercoagulable state. The association between MA and outcome was stronger than that between traditional biomarkers and was independent of age and Hunt Hess grade.


Subject(s)
Blood Coagulation/physiology , Subarachnoid Hemorrhage/diagnosis , Subarachnoid Hemorrhage/physiopathology , Thrombelastography/methods , Aged , Female , Humans , Logistic Models , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies
8.
Neurocrit Care ; 22(1): 45-51, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25127903

ABSTRACT

INTRODUCTION: Traumatic brain injury (TBI) is associated with a hypercoagulable state, the mechanism and duration of which remain unclear. We sought to determine whether thromboelastography (TEG) analysis could identify the hypercoagulable state after TBI, as defined by elevations in maximal amplitude (MA), thrombus generation (TG), G value (G), and alpha angle (αA). METHODS: Patients with moderate-severe TBI, defined primarily as a GCS <12, admitted between 1/2012 and 8/2013 were eligible for enrolment in this prospective cohort study. TEG profiles were obtained between 0-24 h (T1), 24-48 h (T2), 48-72 h (T3), 72-96 h (T4), and 96-120 h (T5) after admission. Early TEG was defined as 0-48 h, and late TEG was defined as >48 h. RESULTS: Twenty five patients (80 % men) and 7 age- and sex-matched control subjects were studied. Median age was 38 years (range 18-85). Early MA was [63.6 mm (60.5, 67.4)] versus late MA [69.9 mm (65.2,73.9); p = 0.02], early TG was [763.3 mm/min (712.8, 816.2)] versus late TG [835.9 mm/min (791.2,888.3); p = 0.02], and early G was [8.8 d/cm(2) (7.7,10.4)] versus late G [11.6 d/cm(2) (9.4,14.1); p = 0.02]. Study patients had higher MA (p = 0.02), TG (p = 0.03), and G (p = 0.02) values at T5 compared to controls. There was a linear increase per day of MA by 2.6 mm (p = 0.001), TG 31.9 mm/min (p ≤ 0.001), and G value by 1.3 d/cm(2) (p ≤ 0.001) when clustered by pairs in regression analysis. Lower MA values trended toward home discharge (p = 0.08). CONCLUSION: The data suggest a progressive and delayed hypercoagulable state observed days after initial TBI. The hypercoagulable state may reflect excess platelet activity.


Subject(s)
Brain Injuries/complications , Thrombelastography/methods , Thrombophilia/diagnosis , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Pilot Projects , Thrombophilia/etiology , Young Adult
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