Prophylactic Left Atrial Appendage Exclusion in Cardiac Surgery Patients With Elevated CHA2DS2-VASc Score: Results of the Randomized ATLAS Trial.

OBJECTIVE: Patients with elevated CHA2DS2-VASc scores are at high risk for atrial fibrillation (AF) and thromboembolic events (TE) after cardiac surgery. Left atrial appendage exclusion (LAAE) is a permanent, continuous approach to stroke prevention in AF, overcoming limitations of oral anticoagulation (OAC). We report ATLAS trial results focused on LAAE technical success and perioperative safety and TE rates with and without LAAE in cardiac surgery patients who developed postoperative AF (POAF). METHODS: ATLAS (NCT02701062) was a prospective, multicenter, feasibility trial. Patients age ≥18 years, undergoing structural heart procedure, with no preoperative AF, CHA2DS2-VASc ≥2, and HAS-BLED ≥2 were randomized 2:1 to LAAE or no LAAE. Patients who developed POAF and/or received LAAE were followed for 1 year. LAAE was evaluated with intraoperative transesophageal echocardiography. RESULTS: A total of 562 patients were randomized to LAAE (n = 376) or no LAAE (n = 186). Mean CHA2DS2-VASc (3.4 vs 3.4) and HAS-BLED (2.8 vs 2.9) scores were similar for LAAE and no LAAE groups. LAAE success (no flow nor residual stump >10 mm) was 99%. One LAAE-related serious adverse event (0.27%) occurred and was resolved without sequelae. There were 44.3% of patients who developed POAF. Through 1 year, 3.4% of LAAE patients and 5.6% of no LAAE patients had TE. OAC was used by 32.5% of POAF patients. Bleeding was higher with OAC than without (16.1% vs 5.4%, P = 0.008). CONCLUSIONS: ATLAS demonstrated a high rate of successful LAAE with low LAAE-related serious adverse events in cardiac surgery patients. Study results should be considered in future trial design to further evaluate prophylactic LAAE for stroke prevention in cardiac surgery patients with elevated stroke risk.

Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials.

OBJECTIVE: To present a combined analysis of the pregnancy outcomes for women aged up to 45 years enrolled in five phase III clinical studies of the prophylactic quadrivalent human papillomavirus 6/11/16/18 vaccine. METHODS: Twenty thousand five hundred fifty-one women aged 15-45 years received quadrivalent HPV vaccine or placebo at day 1 and months 2 and 6. Urine pregnancy tests were performed immediately before each injection; participants testing positive were not vaccinated. Women who became pregnant after enrollment were discontinued from further vaccination until resolution of pregnancy. All pregnancies were followed for outcomes. RESULTS: During the studies, 1,796 vaccine and 1,824 placebo recipients became pregnant, resulting in 2,008 and 2,029 pregnancies with known outcomes. No significant differences were noted overall for the proportions of pregnancies resulting in live birth, fetal loss, or spontaneous abortion. A total of 40 neonates born to vaccinated women and 30 neonates born to women given placebo had one or more congenital anomalies (P=.20). The anomalies were diverse and consistent with those most commonly observed in the general population. The vaccine was well tolerated among women who became pregnant. CONCLUSION: Administration of quadrivalent human papillomavirus vaccine to women who became pregnant during the phase III clinical trials did not appear to negatively affect pregnancy outcomes. The vaccine is a U.S. Food and Drug Administration pregnancy category B medication (animal studies revealed no evidence of fetal harm, but there are no adequate and well-controlled studies in pregnant women); however, vaccination is not recommended during pregnancy. Postlicensure surveillance is ongoing. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00092521, NCT00092534, NCT00092495, NCT00092547 and NCT00090220. LEVEL OF EVIDENCE: II.

Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America.

Evidence-based guidelines for immunization of infants, children, adolescents, and adults have been prepared by an Expert Panel of the Infectious Diseases Society of America (IDSA). These updated guidelines replace the previous immunization guidelines published in 2002. These guidelines are prepared for health care professionals who care for either immunocompetent or immunocompromised people of all ages. Since 2002, the capacity to prevent more infectious diseases has increased markedly for several reasons: new vaccines have been licensed (human papillomavirus vaccine; live, attenuated influenza vaccine; meningococcal conjugate vaccine; rotavirus vaccine; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis [Tdap] vaccine; and zoster vaccine), new combination vaccines have become available (measles, mumps, rubella and varicella vaccine; tetanus, diphtheria, and pertussis and inactivated polio vaccine; and tetanus, diphtheria, and pertussis and inactivated polio/Haemophilus influenzae type b vaccine), hepatitis A vaccines are now recommended universally for young children, influenza vaccines are recommended annually for all children aged 6 months through 18 years and for adults aged > or = 50 years, and a second dose of varicella vaccine has been added to the routine childhood and adolescent immunization schedule. Many of these changes have resulted in expansion of the adolescent and adult immunization schedules. In addition, increased emphasis has been placed on removing barriers to immunization, eliminating racial/ethnic disparities, addressing vaccine safety issues, financing recommended vaccines, and immunizing specific groups, including health care providers, immunocompromised people, pregnant women, international travelers, and internationally adopted children. This document includes 46 standards that, if followed, should lead to optimal disease prevention through vaccination in multiple population groups while maintaining high levels of safety.

Obstetrician-gynecologists' practices and perceived knowledge regarding immunization.

BACKGROUND: Obstetrician-gynecologists can play a key role in providing appropriate vaccinations to women of childbearing age. PURPOSE: This study investigated immunization knowledge and practices, and opinions concerning potential barriers to immunization, among obstetrician-gynecologists. METHODS: In 2007, surveys were sent to Collaborative Ambulatory Research Network members, a representative sample of practicing Fellows of the American College of Obstetricians and Gynecologists; 394 responded (51.2%). Data analysis was completed in 2008. RESULTS: Most responding obstetrician-gynecologists disagreed that "routine screening for vaccine-preventable diseases falls outside of the routine practice of an ob/gyn." A majority (78.7%) stock and administer at least some vaccines. Among those who stock vaccines, 91.0% stock the human papillomavirus vaccine, and 66.8% stock the influenza vaccine. All other vaccines were stocked by <30% of practices that stock vaccines. A majority of physicians agreed that financial factors (e.g., inadequate reimbursement) were barriers to vaccine administration. Most were aware that the influenza (89.8%); hepatitis B (64.0%); and tetanus, diptheria, pertussis (58.6%) vaccines are safe to administer during pregnancy, and that the measles, mumps, rubella (97.5%); and varicella (92.9%) vaccines are not. Most (84.5%) were in concordance with recommendations that all pregnant women should receive the influenza vaccine. A majority believed their immunization training was less than adequate and believed their practice would benefit from continuing medical education courses. CONCLUSIONS: Immunization is an important part of women's health care and has been, at least partially, incorporated into obstetrician-gynecologist practice. Financial burdens and knowledge regarding vaccine recommendations remain barriers to vaccine administration. Additional training and professional information may benefit obstetric-gynecologic practice.