Kim Eagle, MD, and the editors of ACC.org, present relevant articles taken from various journals
Public Reporting vs. Collaborative Quality Improvement in PCI Outcomes
While the aim of public reporting is to improve clinical outcomes in patients, some studies have shown that public reporting may have a negative impact on patient selection in treatments such as percutaneous coronary interventions (PCI). In collaborative quality improvement (CQI), accountability is promoted through the sharing of information to institutions and providers without public reporting. A recent paper published in the American Heart Journal compared these two systems and found that public reporting is associated with a lower risk of mortality and adverse events compared to CQI.
The study examined all PCI’s performed at centers participating in the ACC’s NCDR CathPCI Registry® from two states: Michigan, a leader in CQI, and New York, a leader in public reporting. A total of 51,983 PCIs in New York and 53,528 PCIs in Michigan were included in the analysis.
Researchers observed significant baseline characteristics between the two groups. A much smaller percentage of New York patients had extremely high predicted risk of mortality compared to Michigan patients. Patients in New York were more likely to undergo appropriate PCI. However, there was also an increased number of PCIs of uncertain appropriateness in New York while there was no difference in inappropriate PCI between the states. At discharge, New York patients were more likely to receive a referral to cardiac rehab, but there was no difference between the states with regard to optimal medical therapy at discharge. Adverse events were generally lower in the New York cohort and there was a lower likelihood of mortality associated with PCI in this group compared to the Michigan cohort.
The authors suggest that public reporting may be superior compared to CQI in improving clinical outcome. However, their observations also confirm previous findings that higher-risk patients are less likely to undergo PCI in states with public reporting.
“As the ACC moves towards [publically reporting] mortality statistics for PCI, and as states and the federal government increase the use of public reporting for more procedures and conditions, it will be important to closely follow use patterns to ensure that this and other reported procedures are being appropriately offered and performed,” the authors write. “It is unlikely that in the era of increasing transparency that [public reporting] will cease; instead, we should focus on leveraging its upsides and limiting its downsides.”
They conclude that the optimal quality improvement method may involve combining both public reporting and CQI strategies “to protect access to care while still driving improvements in patient outcomes.”
Boyden TF, Karen E. Joynt KE, McCoy L, et al. American Heart Journal. 2015;doi: 10/1016/j.ahj.2015.09.006.
Differences Observed in PCI in the U.S. vs. Japan
A recent study comparing patients undergoing percutaneous coronary intervention (PCI) in the United States and Japan has found substantial differences in patient characteristics in the two countries.
For the study, published in the American Heart Journal, patient and procedural characteristics were analyzed from 9,941 patients in the Japan Cardiovascular Database-Keio interhospital Cardiovascular Studies (JCD-KiCS) and 732,345 patients in the ACC’s NCDR CathPCI Registry®.
The researchers found that, at baseline, Japanese patients were older and were more likely to be men, have diabetes and to smoke. Japanese patients also had a lower body mass index and a lower prevalence of peripheral vascular disease and chronic obstructive pulmonary disease. The percentage of PCI performed on an elective basis for unstable angina, non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) were 48.7%, 27.1%, and 24%, respectively, for Japanese patients and 31.7%, 53.9%, and 14.4%, respectively, for U.S. patients. Other demographics, including the prevalence of comorbidities, were similar.
Almost all of the U.S. patients underwent PCI via the femoral approach (95.4%) while 31.8% of patients in Japan underwent PCI via the radial approach. This higher percentage for the radial approach was consistent for all indications for PCI. Japanese patients had a higher rate of complex type lesions such as multivessel disease (68.9% vs. 53.5% p < .001), chronic total occlusions (6.4% vs. 3.2%, p < .001) and bifurcation lesions (26.1 vs 12.7%, p < .001). Japanese patients also experience significantly longer average fluoroscopy time (29.7 ± 21.5 vs. 14.4 ± 11.5 minutes, p < .001).
The majority of patients in both countries were discharged with aspirin and secondary antiplatelet agents such as clopidogrel. In the U.S., 80-90% of patients received beta-blockers compared to 60-70% of Japanese patients. Japanese patients had more periprocedural complications than U.S. patients, including higher bleeding complication rates 72 hours after PCI (2.9% vs. 1.8%, p < .001) and significantly higher in-hospital mortality rates (1.6% vs. 0.9%, p < .001).
A notable finding of the study is that better outcomes were observed in elective patients in the U.S., but Japanese patients experienced better outcomes for PCI for STEMI rather than elective PCI.
“It is important to determine the clinical characteristics and profiles of patients who undergo PCI in different regions, because such data are necessary to evaluate whether patients are being managed appropriately and in line with the available clinical guidelines and evidence-based medicine,” the authors write. “The current findings from two large-scale registries underscore the importance of establishing clinical registry programs using common data elements/standards in individual regions or countries, because their procedural ‘culture’ may differ substantially.” The JCD registry is the first international registry with similar data definitions to those in the NCDR, making it ideal for comparing clinical characteristics of patients in the two countries. Comparative studies such as this one can help evaluate appropriateness and aid in quality improvements.
Kohsaka S, Miyata H, Ueda I, et al. American Heart Journal. 2015;doi:10.1016/ j.ahj.2015.09.017.
TAVR and the Clinical Practice Landscape
The availability of transcatheter aortic valve replacement (TAVR) has had significant effect on clinical practice, according to a recent German study published in the New England Journal of Medicine.
Before the introduction of TAVR in 2007, surgical aortic valve replacement (SAVR) was the only treatment option for aortic stenosis. While SAVR is still considered the standard of care in these patients, TAVR is changing the way some of them are treated.
Jochen Reinöhl, MD, and colleagues examined 55,992 SAVR and 32,581 TAVR patients in Germany between 2007 and 2013 and found significant differences between the patients in each group. Patients undergoing TAVR were older, more likely to be female and were more likely to have coexisting conditions and a history of heart disease. Previous cardiac surgery was more frequent with TAVR than SAVR.
In 2007, there were 8,622 SAVR procedures and only 144 TAVR procedures. After that, the number of SAVR procedures declined to 7,048 in 2013, while TAVR procedures increased with 9,147 performed in 2013. Among SAVR procedures, there was a decline in the use of mechanical prostheses but the use of bioprosthetic implants was mostly unchanged.
The researchers looked closer at the ages of patients and found that rates of SAVR did not change much among patients who were younger than 80-years-old, but there was a moderate decline among those 80-years or older.
In-hospital mortality was significantly higher with TAVR than SAVR (6.5% vs. 2.8%). However, there were significant reductions in mortality for both groups between 2007 and 2013, but the improvement was smaller in SAVR, falling from 3.8% in 2007 to 2.2% in 2013, than TAVR, which fell from 13.2% in 2007 to 5.4% in 2013. Stroke rates were higher with TAVR than SAVR (2.5% vs. 1.8%), as well as rate of acute kidney injury (14.0% vs. 8.2%). The rates of complications generally decreased over time in both groups. In TAVR patients, rates of bleeding and permanent pacemaker implantation decreased significantly, and rates of stroke and acute kidney injury declined, but the rates were not significant. SAVR patients saw significant decreases in rates of stroke, bleeding and permanent pacemaker implantation, but the rates of acute kidney injury increased over time.
These finding show trends towards improvement in outcomes for both TAVR and SAVR. The authors attribute the decline in in-hospital mortality for TAVR to a combination of factors such as a learning curve effect on procedural skills as well as advances in device development. For SAVR, the authors write that the improvement in outcomes was probably due in part to the shift from SAVR to TAVR for high-risk patients.
In a Journal Scan on ACC.org, David S. Bach, MD, FACC, wrote, “The adoption of TAVR in the European Union has been heterogeneous, but in Germany, it has been brisk. These data provide reassurance that TAVR has been used for the most part among patients previously denied SAVR or at high risk for SAVR. The availability of TAVR for high-risk patients likely contributes to the temporal decline in mortality associated with SAVR. The observed temporal decline in mortality associated with TAVR likely is due to operator experience and improvement in devices, with a possible contribution of younger and therefore presumably lower-risk patients undergoing TAVR in more recent years.”
Reinöhl J, Kaier K, Reinecke H, et al. N Engl J Med. 2015;373:2438-47.
Keywords: CardioSource WorldNews Interventions, Japan, Patient Selection, Percutaneous Coronary Intervention, Quality Improvement, Transcatheter Aortic Valve Replacement
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