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May 13, 2012

Review of Cardiac Cath Labs Highlights Strengths and Shortcomings

May 10, 2012—Ten cardiac catheterization laboratories have undergone review by the Accreditation for Cardiovascular Excellence (ACE), according to two studies presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2012 Scientific Sessions in Las Vegas, Nevada.

According to the SCAI press release, all centers welcomed the evaluation by outside experts and prepared for the site visits; however, the review teams found insufficiencies in record-keeping and other quality metrics at the centers. Among the shortcomings found by the ACE review teams were medical records missing key clinical information, cardiac catheterization reports lacking data needed to determine patient risk, and inconsistent use of random case reviews as a tool for ensuring quality and appropriateness. A significant amount of variation in documentation among sites was also seen during these reviews.

ACE accredits facilities that perform cardiovascular procedures such as cardiac catheterization and percutaneous coronary intervention (PCI). It is a nonprofit organization that was launched in May 2009 with support from SCAI and the American College of Cardiology Foundation. ACE issued its first accreditation in May 2011. Bonnie H. Weiner, MD, is the Board Chair and Chief Medical Officer for ACE, which is based in Washington, DC. Dr. Weiner is also a past president of SCAI.

Dr. Weiner noted that the cardiac catheterization labs in these studies volunteered to be the first to undergo ACE accreditation; they were confident of being high-quality facilities but wanted to be even better and sought outside expertise to accomplish that goal. “It really comes down to the documentation,” commented Dr. Weiner. “As physicians, we're doing a good job taking care of the patients, but in terms of quality processes, we could do better.”

As summarized in the SCAI announcement, investigators in the first study gathered data on quality processes from the first 10 medical centers to undergo ACE review. They examined a total of 441 medical records from patients who underwent cardiac catheterization, PCI, or both.

The first ACE study found that more than 93% of charts earned good marks for the completeness of most clinical data. However, certain areas showed a need for improvement. Radiation exposure was documented in only 87%, and a combination of x-ray exposure time and absorbed radiation dose was documented in 77.5%. Information on the severity of angina was present in 28% of records, the extent of the risk associated with the patient's coronary artery disease based on stress testing was stated in 8%, and the patient's functional status (New York Heart Association class) was stated in 21.8% of records. Other clinical information needed by the National Cardiovascular Data Registry to assess the risk of patients treated with PCI was missing from many records, making it difficult for reviewers to validate the accuracy of the data submitted to the database.

In the second study presented at the SCAI meeting, ACE investigators examined 478 randomly selected angiograms and the accompanying catheterization reports from the same 10 facilities.

The investigators found that the results of PCI were adequate in 89% of cases. However, the reports often contained insufficient or unclear information on patient risk and the appropriateness of PCI. For example, evidence of ischemia was documented in only 46% of patients. Approximately 8% of patients had intravascular ultrasound or another test to determine whether PCI was needed, but half of these studies were inadequate or indeterminate, and documentation was poor. Overall, only 66% of nonurgent PCIs could be deemed appropriate based on the angiogram and information available in the catheterization report. In 26% of cases, the appropriateness of PCI was considered uncertain primarily because of the limited documentation, and 8% of procedures were deemed inappropriate.

“The cath report really needs to be a stand-alone document that includes risk characteristics as well as appropriate use criteria characteristics, so that in a single package people can see why you did the case, what you did, and what the results were,” stated Dr. Weiner. “Every hospital can benefit from external review. An objective outside observer can constructively deliver to the facility the message, ‘You need to do better in these areas.' It can be an effective way to engage their physicians and their quality teams in moving forward—and sometimes to get their administration to invest needed resources.”

On May 8, SCAI and the American College of Cardiology Foundation announced the publication of the consensus statement, “2012 ACCF/SCAI Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update.” On March 20, SCAI announced that its “Clinical Expert Consensus Statement on Best Practices in the Cardiac Catheterization Laboratory” was published in Catheterization and Cardiovascular Interventions, which was also reported in Cardiac Interventions Today.

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May 14, 2012

Boston Scientific's Watchman LAA Closure Device Demonstrates Reduced Stroke Risk for AF Patients

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Boston Scientific's Watchman LAA Closure Device Demonstrates Reduced Stroke Risk for AF Patients


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