Prospective study of venous thromboembolism in patients with head and neck cancer after surgery.

IMPORTANCE: Venous thromboembolism (VTE) is associated with significant morbidity and mortality in surgery patients, but little data exist on the incidence of VTE in head and neck cancer surgical patients. OBJECTIVE: To determine the incidence of VTE in postoperative patients with head and neck cancer. DESIGN, SETTING, AND PARTICIPANTS: A prospective study of 100 consecutive patients hospitalized at a tertiary care academic surgical center who underwent surgery to treat head and neck cancer. Routine chemoprophylaxis was not used. On postoperative day (POD) 2 or 3, participants received clinical examination and duplex ultrasonographic evaluation (US). Participants with negative findings on clinical examination and US were followed up clinically; participants with evidence of deep venous thrombosis (DVT) or pulmonary embolism (PE) were given therapeutic anticoagulation. Participants with superficial VTE underwent repeated US on POD 4, 5, or 6. Participants were monitored for 30 days after surgery. MAIN OUTCOME AND MEASURE: Total number of new cases of VTE (superficial and deep) identified within 30 days of surgery and confirmed on diagnostic imaging. RESULTS: Of the 111 participants enrolled, 11 withdrew before completing the study; thus, 100 participants were included. The overall incidence of VTE was 13%. Eight participants were identified with clinically significant VTE: 7 DVT and 1 PE. An additional 5 participants had asymptomatic lower extremity superficial VTE detected on US alone. Fourteen percent of patients received some form of postoperative anticoagulation therapy; the rate of bleeding complications in these patients (30.1%) was higher than that in patients without anticoagulation therapy (5.6%) (P = .01). CONCLUSIONS AND RELEVANCE: Hospitalized patients with head and neck cancer not routinely receiving anticoagulation therapy after surgery have an increased risk of VTE. Bleeding complications are elevated in patients receiving postoperative anticoagulation.

Prospective study of venous thromboembolism in patients with head and neck cancer after surgery: interim analysis.

OBJECTIVES: To prospectively determine the incidence of venous thromboembolism (VTE) following major head and neck surgery. At the midpoint of enrollment, an interim analysis was performed to determine if it was ethical to continue this study as an observational study without routine anticoagulation. DESIGN: Prospective, observational cohort study. SETTING: Academic surgical center. PATIENTS: The interim analysis comprised 47 subjects. MAIN OUTCOME MEASURE: The total number of new cases of VTE (superficial and deep) identified within 30 days of surgery and confirmed on diagnostic imaging. These cases were further categorized as clinically relevant and nonclinically relevant. Clinically relevant VTEs were those requiring more than 6 weeks of anticoagulation or were associated with any negative impact on clinical course. On postoperative day 2 or 3, subjects were clinically examined and received duplex ultrasonography. Subjects with negative findings from examination and ultrasonography were followed up clinically; subjects with evidence of deep venous thrombus or pulmonary embolism were given therapeutic anticoagulation. Subjects with superficial VTE received repeated ultrasonography on postoperative days 4 to 6. Subjects were monitored for 30 days after surgery. RESULTS: Three subjects (6%) were identified as having clinically significant VTE: 2 cases of deep venous thrombus and 1 case of pulmonary embolism. Two additional subjects had lower extremity superficial VTE without clinical findings, which were detected by ultrasonography alone. No statistically significant differences were seen between patients with VTE and those without VTE. CONCLUSIONS: This interim analysis of the first prospective study of the incidence of VTE in patients with head and neck cancer showed a VTE rate slightly higher than previously estimated in retrospective studies. There have been no unexpected serious adverse events and no rationale for early termination of the study.

Retrospective analysis of a local cessation of vaccination against poliomyelitis: a possible scenario for the future.

The global eradication of poliomyelitis will require substantial changes in immunization practices. One of the proposed scenarios includes cessation of vaccination with live oral poliovirus vaccine (OPV) and the creation of an OPV stockpile for emergency response in case of the reintroduction of poliovirus into circulation. We describe here a retrospective analysis of the cessation of OPV usage in a region of the Byelorussian Republic of the former Soviet Union in 1963 to 1966. During this period, a widespread circulation and evolution of independent lineages of vaccine-derived polioviruses took place in the region. Some of these lineages appeared to originate from OPV given to 40 children in the community during this period of essentially no vaccinations. The data demonstrate very high risks associated with both the local cessation of OPV vaccination and the proposed use of OPV to control a possible reemergence of poliovirus in the postvaccination period. The high transmissibility of OPV-derived viruses in nonimmune population, documented here, and the known existence of long-term OPV excretors should be also considered in assessing risks of the synchronized global cessation of OPV usage.