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Blood ; 140(3): 163-164, 2022 07 21.
Article in English | MEDLINE | ID: covidwho-1951020

COVID-19 , Hematology , Humans
Ann Intern Med ; 175(4): 513-522, 2022 04.
Article in English | MEDLINE | ID: covidwho-1811218


BACKGROUND: Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. It presents similarly to spontaneous heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis after vaccination with the Ad26.COV2.S COVID-19 vaccine (Janssen/Johnson & Johnson) have previously been described. OBJECTIVE: To describe surveillance data and reporting rates of all reported TTS cases after COVID-19 vaccination in the United States. DESIGN: Case series. SETTING: United States. PATIENTS: Case patients receiving a COVID-19 vaccine from 14 December 2020 through 31 August 2021 with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction) reported to the Vaccine Adverse Event Reporting System. If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for antiplatelet factor 4 antibodies or functional heparin-induced thrombocytopenia platelet test result was required. MEASUREMENTS: Reporting rates (cases per million vaccine doses) and descriptive epidemiology. RESULTS: A total of 57 TTS cases were confirmed after vaccination with Ad26.COV2.S (n = 54) or a messenger RNA (mRNA)-based COVID-19 vaccine (n = 3). Reporting rates for TTS were 3.83 per million vaccine doses (Ad26.COV2.S) and 0.00855 per million vaccine doses (mRNA-based COVID-19 vaccines). The median age of patients with TTS after Ad26.COV2.S vaccination was 44.5 years (range, 18 to 70 years), and 69% of patients were women. Of the TTS cases after mRNA-based COVID-19 vaccination, 2 occurred in men older than 50 years and 1 in a woman aged 50 to 59 years. All cases after Ad26.COV2.S vaccination involved hospitalization, including 36 (67%) with intensive care unit admission. Outcomes of hospitalizations after Ad26.COV2.S vaccination included death (15%), discharge to postacute care (17%), and discharge home (68%). LIMITATIONS: Underreporting and incomplete case follow-up. CONCLUSION: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the 3 cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.

COVID-19 , Thrombocytopenia , Thrombosis , Vaccines , /adverse effects , Adolescent , Adult , Aged , COVID-19/epidemiology , COVID-19 Vaccines/adverse effects , Female , Humans , Male , Middle Aged , RNA, Messenger , Syndrome , Thrombocytopenia/chemically induced , Thrombocytopenia/epidemiology , Thrombosis/chemically induced , Thrombosis/etiology , United States/epidemiology , Vaccination/adverse effects , Vaccines/adverse effects , Young Adult
JAMA Intern Med ; 181(12): 1621-1622, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1453496
Blood ; 136(Supplement 1):23-24, 2020.
Article in English | PMC | ID: covidwho-1339094


Introduction: Early studies identified a prothrombotic state associated with novel coronavirus disease 2019 (COVID-19) as well as a survival benefit observed with heparin use in severely ill COVID-19 patients. There is a need to clarify the incidence of thromboembolic events (TEs), as well as major hemorrhage in COVID-19 patients in the context of an escalated-dose thromboprophylaxis strategy.Methods: We conducted a single center, retrospective study of 192 consecutive patients with COVID-19 admitted to the hospital between March 26th and May 8th 2020. Our study aimed to investigate the rates of thromboembolic events (TEs), hemorrhage and mortality of in the context of an escalated-dose thromboprophylaxis strategy implemented early in our experience with hospitalized patients with COVID-19.Results: The incidence of radiographically-confirmed venous thromboembolism (VTE) was 7.3% (n=14), and the rate of combined TEs was 12% (n=23). The rate of major hemorrhage was 6.3% (n=12), including one fatal CNS bleed. The overall mortality rate was 27.6% (n=53).Conclusion: The rate of VTE and overall TE was much lower than was reported in early studies, and the majority of VTEs occurred in ambulatory patients. Our data suggest that an escalated-dose thromboprophylaxis strategy may help reduce the incidence of inpatient VTEs, and that ambulatory COVID-19 patients may benefit from primary thromboprophylaxis. However, the risk of bleeding was not negligible, and must therefore be assessed on an individual and continual basis when using a more aggressive thromboprophylaxis strategy.

Blood ; 138(4): 293-298, 2021 07 29.
Article in English | MEDLINE | ID: covidwho-1331924


The development of vaccines to fight COVID-19 has been a remarkable medical achievement. However, this global immunization effort has been complicated by a rare vaccine-related outcome characterized by thrombocytopenia and thrombosis in association with platelet-activating anti-platelet factor 4 antibodies. In this Spotlight, we will discuss the recently described complication of vaccine-induced immune thrombotic thrombocytopenia (VITT) occurring in response to certain COVID-19 vaccines. Although information about this clinical condition is rapidly evolving, we will summarize our current understanding of VITT.

COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Purpura, Thrombocytopenic, Idiopathic/etiology , Anticoagulants/adverse effects , Anticoagulants/immunology , COVID-19/immunology , COVID-19 Vaccines/immunology , COVID-19 Vaccines/therapeutic use , Disease Management , Heparin/adverse effects , Heparin/immunology , Humans , Purpura, Thrombocytopenic, Idiopathic/immunology , Purpura, Thrombocytopenic, Idiopathic/therapy , SARS-CoV-2/immunology
J Thromb Haemost ; 18(9): 2138-2144, 2020 09.
Article in English | MEDLINE | ID: covidwho-641045


Hypercoagulability is an increasingly recognized complication of SARS-CoV-2 infection. As such, anticoagulation has become part and parcel of comprehensive COVID-19 management. However, several uncertainties exist in this area, including the appropriate type and dose of heparin. In addition, special patient populations, including those with high body mass index and renal impairment, require special consideration. Although the current evidence is still insufficient, we provide a pragmatic approach to anticoagulation in COVID-19, but stress the need for further trials in this area.

Anticoagulants/therapeutic use , Betacoronavirus/pathogenicity , Blood Coagulation Disorders/drug therapy , Blood Coagulation/drug effects , Coronavirus Infections/drug therapy , Pneumonia, Viral/drug therapy , Blood Coagulation Disorders/blood , Blood Coagulation Disorders/mortality , Blood Coagulation Disorders/virology , COVID-19 , Clinical Decision-Making , Coronavirus Infections/blood , Coronavirus Infections/mortality , Coronavirus Infections/virology , Host-Pathogen Interactions , Humans , Pandemics , Patient Selection , Pneumonia, Viral/blood , Pneumonia, Viral/mortality , Pneumonia, Viral/virology , Risk Factors , SARS-CoV-2 , Treatment Outcome