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WASHINGTON (Jul 05, 2017) -
Data from the American College of Cardiology's National Cardiovascular Data Registry was the source in a decision to expand use of an artificial valve and for several published studies, including a study measuring volume of percutaneous coronary interventions performed by operators and on delays in treatment for black and female heart attack patients.
FDA Cites STS/ACC TVT Registry Data to Expand Use of Sapien 3 Artificial Heart Valve
The U.S. Food and Drug Administration (FDA) recently approved expanding the use of Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater. As a part of this approval, this FDA evaluated data from the STS/ACC TVT Registry, a partnership of the American College of Cardiology and the Society of Thoracic Surgeons. The registry collects clinical data on the safety and effectiveness of transcatheter valve replacement procedures performed in a real-world setting. Read more.
Study Suggests It's Uncommon For Type 2 Diabetes Patients Not to Have Other Cardio-Renal-Metabolic Conditions
It is uncommon for patients to have Type 2 diabetes without other cardio-renal-metabolic (CaReMe) conditions, according to research presented during the American Diabetes Association Scientific Sessions in San Diego. As such, there is a "clinical need for novel Type 2 diabetes treatment strategies that address both glycemia and coexisting disease states in this high-risk patient group," said study authors Robert J. LoCasale, MD, et al. The cross-sectional study used data from the Diabetes Collaborative Registry between January 2013 and June 2016. A total of 530,747 patients aged 18 years or older with Type 2 diabetes were eligible for inclusion in the study. Patients with Type 1 diabetes were excluded. Results found that most patients (95.7 percent) had at least one other CaReMe condition in addition to Type 2 diabetes, with the most prevalent being hypertension, hyperlipidemia, coronary artery disease and chronic kidney disease. More than half of patients (58.6 percent) had at least three additional CaReMe conditions. Read more.
NCDR Study Finds PCI Operators Perform Low Volume of PCI Procedures Annually
Many PCI operators in the U.S. perform fewer than the recommended number of PCI procedures annually, according to a study published June 12 in the Journal of the American College of Cardiology. Using data from the ACC's CathPCI Registry, Alexander C. Fanaroff, MD, et al., looked at operator annual PCI volume between July 2009 and March 2015. Operators were divided into low- (less than 50 PCIs per year), intermediate- (50 to 100 PCIs per year) and high- (more than 100 PCIs per year) volume groups. Results showed that the median annual number of procedures performed per operator was 59, and 44 percent of operators performed less than 50 PCI procedures per year – the number of procedures recommended by the ACC/AHA/SCAI 2013 Update of the Clinical Competence Statement on Coronary Artery Interventional Procedures. In addition, low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators. Read more.
NCDR Study Shows Longer Delay Times Persist For Black AMI Patients
Black patients with acute myocardial infarction (AMI) continue to experience a longer delay in time to presentation compared to white patients, according to a study published April 15 in the American Journal of Cardiology. Amy Leigh Miller, MD, PhD, FACC, et al., looked at patient data from the ACC's ACTION Registry and socioeconomic and community information from the American Community Survey. Among the 346,499 AMI patients treated at 744 hospitals, 11 percent (38,875) were of the black race. Results showed that the black patient group was less likely to have STEMI as compared to the white patient group (37.7 percent vs. 42.8 percent), but more likely to experience signs of cardiogenic shock or heart failure once at the hospital (17.8 percent vs. 15 percent). In regards to socioeconomic factors, the authors found "black patients were more likely to reside in communities with higher proportions of single-person households, unmarried people, and high residence turnover, suggesting greater social isolation." Read more.
Does Gender Impact Contact-to-Device Time and Mortality in STEMI Patients?
Female patients with STEMI may experience longer contact-to-device times and have a higher in-hospital mortality rate compared to male patients with STEMI, according to a study published Jan. 11 in the Journal of the American Heart Association. Robert O. Roswell, MD, FACC, et al., used the ACC's ACTION Registry to analyze the outcomes of 102,515 STEMI patients at 760 sites from January 2007 to December 2014. Female STEMI patients only represented 27.2 percent of the study's population, but had a higher median age and incidence of comorbidities. They were also more likely to be enrolled in Medicare, alert EMS of their symptoms and arrive by ambulance. Results showed that only 67.5 percent of female patients achieved the target contact-to-device time (≤90 minutes) compared to 75.6 percent of male patients. Furthermore, female patients had longer total ischemic times (161 minutes vs. 145 minutes) and a higher in-hospital mortality rate (4.1 percent vs. 2.0 percent) compared to male STEMI patients. While improving patient education about the symptoms of an acute coronary syndrome is necessary to lessen symptom onset to contact time, the authors state that "further investigation is needed to mitigate the sex-specific circumstances that exacerbate the risk of mortality for female STEMI patients." Read more.
NCDR Study Examines Potential Implications of the PEGASUS-TIMI 54 Trial
New research looking at the use and cost implications of P2Y12 inhibitors found that they are not routinely used in the long-term care of myocardial infarction (MI) patients, and there is a higher cost per ischemic event for ticagrelor vs. clopidogrel, according to a study published April 21 in Open Heart. Steven M. Bradley, MD, FACC, et al., aimed to assess the real-world implications of the PEGASUS-TIMI 54 Trial using patients from the ACC's ACTION Registry as part of ACC's Research to Practice initiative – which identifies impactful cardiovascular research and analyzes its implications for contemporary clinical practice using ACC's NCDR clinical registries. Researchers looked at data between October 2010 and April 2013, and found that 41.1 percent of the 273,328 MI patients identified would have met the eligibility criteria for the trial. Results showed that among the 83,871 eligible patients with pharmacy claims data, only 27.5 percent were on a P2Y12 inhibitor one year post-MI, however usage declined at two and three years post-MI (11.5 percent and 6.3 percent, respectively), with the majority (79.2 percent) of these patients on clopidogrel. Read more.
More TAVR Experience Leads to Better Patient Outcomes
Hospitals where a greater number of transcatheter aortic valve replacement (TAVR) procedures are performed have better patient outcomes, suggesting that concentrating experience in higher volume heart valve centers might be a means of improving outcomes, according to a study published June 26 in the Journal of the American College of Cardiology. John D. Carroll, MD, FACC, et al., examined data from 42,988 procedures conducted at 395 hospitals participating in The Society of Thoracic Surgeons/ACC Transcatheter Valve Therapy (TVT) Registry from 2011 to 2015 to assess in-hospital major adverse events. Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003) and bleeding (p < 0.001), but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume–outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57 percent to 2.15 percent), bleeding (9.56 percent to 5.08 percent), vascular complications (6.11 percent to 4.20 percent) and stroke (2.03 percent to 1.66 percent). These rates were calculated for the "average" patient who carries the average characteristics of the overall study population. The association between TAVR volume and outcomes was most pronounced in the first 100 cases, indicating that there may be an early learning curve for the procedure. Beyond the initial 100 cases, procedural risk continued to decline but at a more gradual rate. Read more.
NCDR data was also used in studies previously highlighted during this time period. Read more:
The American College of Cardiology is the professional home for the entire cardiovascular care team. The mission of the College and its more than 52,000 members is to transform cardiovascular care and to improve heart health. The ACC leads in the formation of health policy, standards and guidelines. The College operates national registries to measure and improve care, offers cardiovascular accreditation to hospitals and institutions, provides professional medical education, disseminates cardiovascular research and bestows credentials upon cardiovascular specialists who meet stringent qualifications. For more, visit acc.org.