PCI California Audit Monitored Pilot With Offsite Surgery

Design: The PCI California Audit Monitored Pilot with Offsite Surgery (PCI-CAMPOS) program is a prospective, multi-center pilot trial allowing elective PCIs at hospitals without on-site cardiovascular surgery in California. The pilot program was established by California Senate Bill No. 891 (SB 891) which was enacted in January 2009 authorizing the California Department of Public Health (CDPH) to set up a pilot program to allow California hospitals without surgery on-site to perform elective PCIs. The PCI-CAMPOS program was designed to compare PCI outcomes at the pilot hospitals with offsite cardiac surgery to PCI outcomes at established California hospitals with onsite cardiac surgery.

The CDPH requested pilot hospital applications in December 2009, selected 6 hospitals out of over 30 applicant hospitals in May 2010 and contracted with University of California, Davis (UCD) to train, audit, and monitor the program. The CDPH appointed a 12 member Advisory Oversight Committee (AOC) with 6 at-large members nominated by the California American College of Cardiology (CAACC) and 6 members from the pilot hospitals (1 principal investigator from each participating pilot hospital). The pilot program was funded by CDPH from fee assessments of participating pilot hospitals. The study was approved by the Institutional Review Board (IRB) at each pilot hospital and at the University of UCD coordinating center, and each patient is asked to provide written informed consent for pilot participation (unless unavailable in critically ill patients).

The National Cardiovascular Data Registry (NCDR®) CathPCI Registry (v. 4.3, 4.4) was selected as the data entry format for both pilot hospitals and non-pilot hospitals. The pilot PCI data is entered using the NCDR® CathPCI Registry v.4.3 and v.4.4 on an internet accessible UCD Velos server (Velos eResearch v9.1.2, Velos, Inc., Fremont, CA). The non-pilot hospitals enter their data using various NCDR® approved onsite software or the central NCDR® CathPCI v.4.3 and v.4.4 website. The pilot hospital data is entered within 72 hours of each procedure and immediately available to the PCI-CAMPOS coordinating center. The non-pilot data is entered individually or obtained from quarterly data harvests submitted to NCDR®. After masking patient, operator, and hospital identity, this non-pilot California NCDR® CathPCI registry data is downloaded annually from the NCDR® center to the UCD PCI-CAMPOS coordinating center. The UCD coordinating center performs all pilot audits and has full access to the pilot information. The UCD coordinating center performs all pilot and comparative analyses. Interim data summaries and analyses are presented to the full AOC for review at 6-12 month intervals throughout the study.

Outcomes: The pilot hospital outcomes are compared with hospital outcomes from non-pilot California hospitals performing either elective PCIs with surgery on-site or ST segment elevation myocardial infarction (STEMI) only PCIs. The non-pilot clinical data is obtained from the 120 California hospitals that submit their clinical data directly to the NCDR® data center and is used for the analysis of the data. Both the non-pilot and pilot data sets are analyzed and compared using SAS statistical software (version 9.3 for Windows, SAS Institute, Cary, NC).

Study Participants Hospitals: The non-pilot hospital group consists of all 120 California hospitals which submit PCI data directly to the NCDR® central database. For all elective PCIs, these hospitals have on-site surgery available for any post-PCI patients who require emergency coronary artery bypass graft (CABG) surgery.