How to use patient safety indicators to monitor vascular surgery technologies.

Abstract

It is important for surgeons to review the safety of new technology, andRose andcolleagues1 in this issueof JAMASurgery have used Patient Safety Indicators (PSIs)2 to compare endovascular and open abdominal aortic aneurysm repair. The results, perhaps not surprisingly, showthat endovascular repair is safer thanopenrepair.Endovascular repair (3.0%) was less likely tohaveaPSI comparedwithopen repair (11.2%). In fact, the study confirms what vascular surgeons have already put into practice as endovascular repair has surpassed open repair in the past decade. The importance of the article is that it critically appraises a technology, in this case a new approach to aneurysm repair. Furthermore, it gives guidelines for how this analysis can be applied to other surgical innovations. The study cannot answer whether endovascular repair is beneficial in the long term because PSIs evaluate patients for only a 30-day period. Moreover, the mortality for open repair (10.6% vs 1.8% for endovascular repair) was higher than one wouldanticipate for thisapproachandlikely indicates that,during theperiodof the study, open repair remained thepreferred technique for emergency operations and for patients who had unfavorable anatomy for endovascular aneurysm repair. Patient Safety Indicators will likely be reportedmore frequently in the surgical literature andmust be understood differently than surgical complications. Preexisting conditions, suchas infectionor immunocompromised state, excludedpatients from the analysis (note the different denominators for PSIs in Table 2 byRose et al1).Whereas surgical complications can be due to surgeon, hospital, and patient characteristics, PSIs exclude preexisting conditions and are a tool for analyzing theeffectof thehospital treatmentaloneonoutcomes.This makes PSIs uniquely suited to analyzing surgical technology, even among heterogeneous patient populations. As the authorspoint out, therewasno increase in the total number of abdominal aortic aneurysm repairs in the United States during the study period (2003-2010), despite increased safety of endovascular repair. To the credit of vascular surgeons, guidelines establishedby theAneurysmDetection and ManagementVeteransAffairs Cooperative Study3 for repair of aneurysm continue to be followed.