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August 23, 2016

English Study Finds Women Have Increased Mortality and Morbidity After AAA Repair

August 24, 2016—In a study conducted to quantify the difference in long-term survival and cardiovascular morbidity between women and men undergoing elective abdominal aortic aneurysm (AAA) repair at National Health Service hospitals in England, investigators concluded that women had increased short- and long-term mortality and postoperative morbidity compared with men. Mital Desai, MD, et al published the study online in European Heart Journal.

The investigators used the Hospital Episode Statistics and Office for National Statistics datasets to review patients having elective repair of AAAs. A total of 31,090 patients (4,795 women and 26,295 men) underwent open AAA repair between April 1, 2002, and March 31, 2013. A total of 16,777 patients (2,036 women and 14,741 men) underwent endovascular aneurysm repair (EVAR) between January 1, 2006, and March 31, 2013.

The primary outcome measure was 30-day mortality and the secondary outcomes were 1-year, 5-year, and aortic-related mortality and postoperative complication rates. Logistic regression and survival models were used to assess risk factors on the primary and secondary outcomes. 

As summarized in European Heart Journal, all-cause and aortic-related mortalities at 30 days, 1 year, and 5 years were all higher in women, despite a lower prevalence of preoperative cardiovascular risk factors. Female sex was a significant independent risk factor for 30-day mortality in both the open repair group (odds ratio [OR], 1.39; 95% confidence interval [CI], 1.25–1.56; P < .001) and the EVAR group (OR, 1.57; 95% CI, 1.23–2; P < .001). 

Based on an all-cause long-term survival model, conditional on 30-day survival, the estimated hazard for women in the open repair group was significantly (P = .006) higher than men, but the sex difference was not significant in the EVAR group (P = .356). 

In the open repair group, women had significantly (P < .001) higher cumulative incidence probabilities for both aortic-related mortality and other-cause mortality. In the EVAR group, women had significantly (P < .001) higher mean cumulative incidence probabilities for the aortic-related mortality compared with men, but not for the other-cause mortality (P = .235).

These findings can be used to improve preoperative counseling for women undergoing AAA repair and highlight the need for female-specific pre-, peri-, and postoperative management strategies, advised the investigators in European Heart Journal.

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August 24, 2016

FDA and Industry Groups Announce Tentative Accord to Reauthorize Medical Device User Fee Agreement

August 24, 2016

FDA and Industry Groups Announce Tentative Accord to Reauthorize Medical Device User Fee Agreement