Hemostatic efficacy of an advanced bipolar sealer in open gynecologic, thoracic, and colectomy procedures: A prospective cohort study

Background An advanced bipolar (ABP) tissue sealer designed for division of major vessels in open procedures was evaluated in a prospective post-market study. The objective was to provide clinical data for assessment of vessel transection, hemostatic performance and ease of use of the ABP device during open colectomy, gynecologic, and thoracic operations. Materials and methods The ABP test device was used in colectomy (n = 36), gynecologic (n = 44), and thoracic (n = 21) procedure groups. Vessels transected with the ABP device were graded intraoperatively on a hemostasis scale of 1–4, defined as follows: Grade1, no bleeding; Grade 2, minor bleeding with no intervention; Grade 3, minor bleeding requiring touchup with the test device or monopolar cautery; and Grade 4, significant bleeding requiring intervention with any additional hemostatic product. The primary performance measure was the percentage of vessels that achieved hemostasis grades ≤3. The primary safety endpoint was the summarization of all ABP device-related adverse events (AEs). Results For all three procedure groups together, 302 (96.2%) of 314 total vessel transections were scored as hemostasis grades ≤ 3, including 270 (86.0%) that were rated Grade 1. Twelve transections (3.8%) were Grade 4, which included 9 vessels transected in the gynecologic group and 3 in the thoracic group. Three subjects experienced a total of 4 device-related AEs, consisting of hematoma, hypotension, procedural pain, and superficial thermal burn. All 4 device-related AEs were mild in severity. Conclusion The advanced bipolar device exhibited effective hemostasis, an acceptable safety profile, and ease of use during colectomy, thoracic, and gynecologic procedures

A Serologic Follow-up of the 1942 Epidemic of Post-Vaccination Hepatitis in the United States Army

An epidemic of icteric hepatitis in 1942 affected approximately 50,000 U.S. Army personnel. This outbreak was linked to specific lots of yellow-fever vaccine stabilized with human serum. To identify the responsible virus and the consequences of the epidemic, during 1985 we interviewed and serologically screened 597 veterans who had been in the army in 1942. These subjects were selected from three groups. Group I consisted of patients who had received the implicated vaccine and had jaundice; Group II had received the implicated vaccine but remained well; Group III had received a new, serum-free vaccine, with no subsequent jaundice. Ninety-seven percent of Group I, 76 percent of Group II, and 13 percent of Group III were positive for antibodies to hepatitis B virus. Only one subject had hepatitis B surface antigen, for a carrier rate of 0.26 percent among recipients of the implicated vaccine. The prevalence of hepatitis A antibody was similar in all three groups, and no subject had antibody to hepatitis delta virus. We conclude that hepatitis B caused the outbreak, that about 330,000 persons may have been infected, that the hepatitis B virus carrier state was a rare consequence, and that the outbreak induced hepatitis B antibodies that appear to persist for life. (N Engl J Med 1987; 316:965–70.) A DRAMATIC outbreak of acute viral hepatitis occurred in 1942 and affected approximately 50,000 U.S. Army servicemen. 1 2 3 4 Investigation of the epidemic suggested that it was related to the receipt of yellow-fever vaccine stabilized with pooled human serum, prompting withdrawal of the vaccine and later replacement with a serum-free vaccine. Thereafter, the epidemic subsided. The virus responsible for the outbreak has not been identified, although epidemiologic characteristics have suggested that it was probably hepatitis B. If so, studying the epidemic would provide a unique opportunity to determine the long-term consequences of hepatitis B virus infection among young healthy adults. Unfortunately, neither . . 

Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: a prospective cohort study.

BACKGROUND Circular staplers perform a critical function for creation of anastomoses in colorectal surgeries. Powered stapling systems allow for reduced force required by surgeons to fire the device and may provide advantages for creating a secure anastomosis. The objective of this study was to evaluate the clinical performance of a novel circular powered stapler in a post-market setting, during left-sided colectomy procedures. MATERIALS AND METHODS Consecutive subjects underwent left-sided colorectal resections that included anastomosis performed with the ECHELON CIRCULAR™ Powered Stapler (ECP). The primary endpoint was the frequency in which a stapler performance issue was observed. Secondary endpoints included evaluation of ease of use of the device via a surgeon satisfaction questionnaire, and monitoring/recording of procedure-related adverse events (AEs). RESULTS A total of 168 anastomoses were performed with the ECP. Surgical approaches included robotic-assisted (n= 74, 44.0%), laparoscopic (n=71, 42.3%), open (n=20, 11.9%), and hand-assisted minimally invasive (n=3, 1.8%) procedures. There were 22 occurrences of device performance issues in 20 (11.9%) subjects during surgery. No positive intraoperative leak tests were observed, and only 1 issue was related to a procedure-related AE or surgical complication, which was an instance of incomplete surgical donut necessitating re-anastomosis. Postoperative anastomotic leaks were experienced in 4 (2.4%) subjects. Clavien-Dindo classification of all AEs indicated that 92.0% were Grades I or II. Participating surgeons rated the ECP as easier to use compared to previously used manual circular staplers in 85.7% of procedures. CONCLUSION The circular powered stapler exhibited few clinically relevant performance issues, an overall favorable safety profile, and ease of use for creation of left-sided colon anastomoses