Contact: Katie Glenn, kglenn@acc.org, 2023756472

WASHINGTON (Aug 15, 2018) -

Data from the American College of Cardiology's NCDR was the source of several studies published and presented in recent months, including a TAVR risk model, urgent/emergent TAVR outcomes, the ACC's Patient Navigator Program and PCSK9 eligibility.

Risk Model For 30-Day Mortality After TAVR Allows Benchmarking, Quality Assessment

A clinical risk model for 30-day death after TAVR may allow for benchmarking, quality assessment and comparison of short-term mortality across centers as TAVR expands to lower-risk patients and less experienced sites, according to research published March 19 in JACC: Cardiovascular Interventions. Suzanne V. Arnold, MD, MHA, et al., collected data from 21,661 patients in the STS/ACC TVT Registry who underwent TAVR at 188 sites between June 2013 and May 2016. The researchers developed a model to estimate risk for 30-day mortality after TAVR based on pre-procedural factors and access site. The model included factors from the TVT Registry in-hospital mortality model and added patient-reported health status and gait speed. Results showed that of the 21,661 TAVR patients, 4.7 percent died within 30 days. Independent predictors of 30-day mortality included older age, low body weight, poor renal function, peripheral artery disease, home oxygen use, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status and inability to walk. Read more.

Urgent/Emergent TAVR Has Acceptable Outcomes Compared With Elective TAVR

Urgent or emergent transcatheter aortic valve replacement (TAVR) was feasible and had acceptable outcomes, according to results of an STS/ACC TVT registry study presented by Dhaval Kolte, MD, PhD, at ACC.18. The results were simultaneously published in JACC: Cardiovascular Interventions. Using data from the STS/ACC TVT registry for TAVR procedures performed from 2011 to 2016, the study cohort was categorized into urgent/emergent TAVR vs. elective TAVR groups. Among the 40,042 patients who underwent TAVR, 36,090 (90.1 percent) were elective and 3,952 (9.9 percent) were urgent/emergent. Patients undergoing urgent/emergent TAVR had lower left ventricular ejection fraction (LVEF) and were more likely to have moderate-to-severe valve insufficiency than those undergoing elective TAVR. Significantly more urgent/emergent TAVR patients had planned valve-in-valve TAVR for degenerated previously implanted bioprostheses. Use of mechanical circulatory support, cardiopulmonary bypass and transapical or transaortic access site was more common in urgent/emergent TAVR. Patients in the urgent/emergent TAVR vs. elective TAVR group had higher intra-procedural mortality (0.96 vs. 0.49 percent) and in-hospital mortality (6.1 vs. 3.0 percent). In-hospital mortality was lower than predicted by the STS/TVT Registry model for both urgent/emergent and elective TAVR. Read more.

ACC's Patient Navigator Program Improves Identification, Readmission Risk For AMI, HF Patients

Implementation of ACC's Patient Navigator Program may lead to substantial improvements in the number of hospitals that prospectively identified and assessed readmission risk for patients with acute myocardial infraction (AMI) and heart failure (HF), according to a poster presented April 7 at the 2018 Quality of Care and Outcomes Research Scientific Sessions in Arlington, Virginia. Tyler J. Gluckman, MD, FACC, et al., analyzed rates of pre-discharge identification and readmission risk assessment for AMI and HF patients who were hospitalized at 35 hospitals that participated in the Patient Navigator Program between 2015 and 2017. All participating hospitals were members of ACC's ACTION Registry, which is now known at the Chest Pain - MI Registry. As Patient Navigator Program participants, the 35 hospitals implemented strategies aimed at improving processes and outcomes of transition care. Institutions received quarterly reports on 36 performance measures, including pre-discharge identification of AMI and HF patients and assessment of their readmission risk. By the end of the study period, 32 hospitals identified AMI patients at risk of readmission before discharge, compared with 24 hospitals at baseline. The number of hospitals identifying HF patients at risk of readmission increased to 34, up from 27 at baseline. At the beginning of the study, nine hospitals assessed readmission risk for AMI patients and 11 hospitals did so for HF patients. After two years, the number of hospitals that completed readmission risk assessments increased to 28 for AMI patients and 30 for HF patients. The researchers conclude that while the Patient Navigator Program led to improvements in identifying and assessing readmission risk for AMI and HF patients, future research is needed to determine whether the improvements led to reductions in 30-day readmissions or other outcome measures. Read more.

Severe MS Associated With Higher Risk of One-Year Adverse Outcomes in Patients Undergoing TAVR

Patients with severe mitral stenosis (MS) undergoing TAVR may have an increased risk of adverse outcomes, including mortality after one year, when compared with patients who do not have MS or whose MS is nonsevere, according to a study published April 2 in JACC: Cardiovascular Interventions. Lee Joseph, MD, MS, et al., used the STS/ACC TVT Registry, along with claims data from the Centers for Medicare and Medicaid Services, to examine 44,755 patients ages 18 and older who underwent TAVR between November 2011 and September 2015. MS was present in 5,201 patients (11.6 percent), with severe MS occurring in 1,214 patients (2.7 percent) and nonsevere MS occurring in 3,987 patients (8.9 percent). After one year, 40.2 percent of patients with severe MS had experienced the primary composite outcome of mortality, stroke, heart failure-related hospitalization and mitral valve intervention, compared with 33.5 percent for patients without MS and 33.7 percent for patients with nonsevere MS. In addition, patients with severe MS had a higher risk of mortality and heart failure-related hospitalization after one year than patients without MS. The researchers conclude that the "higher risk for adverse events must be carefully considered when evaluating patients with combined aortic and MS for TAVR." Learn more.

Higher TR Severity Associated With Increased Mortality, Readmission in TAVR Patients

The risk of mortality and readmission in patients with tricuspid regurgitation (TR) who undergo TAVR may increase based on TR severity, according to a study published March 2 in the Annals of Thoracic Surgery. Fenton H. McCarthy, MD, MS, et al., used the STS/ACC TVT Registry to evaluate the association between TR severity and TAVR outcomes in 34,576 patients who had TAVR between 2011 and 2015. Patients were stratified based on the degree of TR: none, mild, moderate or severe. Of the 34,576 patients, 19.6 percent (6,772) had no TR, 56.1 percent (19,393) had mild TR, 19.3 percent (6,687) had moderate TR, and 5 percent (1,724) had severe TR. The primary outcome of observed-to-expected in-hospital mortality ratio increased based on TR severity and peaked among those with severe TR. Overall in-hospital mortality was 4.5 percent, with the lowest rate in patients with mild TR (3.9 percent) and the highest rate in patients with severe TR (7.6 percent). In addition, patients with severe TR had the highest mortality rate at 30 days (11.3 percent), six months (26.8 percent) and one year (34.2 percent). McCarthy et al., conclude that the effectiveness of TAVR in patients with aortic stenosis and severe TR warrants further research, particularly for lower-risk patients. Read more.

NCDR Study Finds Up to 10 Million U.S. Adults May Be Eligible For PCSK9 Inhibitors

The number of U.S. adults eligible for PCSK9 inhibitors could range from 700,000 to approximately 10 million, according to a study published in American Heart Journal. Paul L. Hess, MD, MHS, et al., used ACC's PINNACLE Registry to assess the impact of LDL-C and statin intensities on the proportion of patients who might be eligible for PCSK9 inhibitor therapy. The researchers defined eligibility using a range of LDL-C thresholds of 70 mg/dL or greater and 160 mg/dL and greater and statin dosing at high intensity, moderate intensity or any intensity. The study population comprised 252,956 patients ages 18 to 75 with available LDL-C data who had prior acute coronary syndrome, coronary or other arterial revascularization, cerebrovascular accident, transient ischemic attack or peripheral arterial disease. Among patients on a high-intensity statin, the proportion of patients potentially eligible for PCSK9 inhibitor therapy increased from 1.9 percent with the threshold of 160 mg/dL or greater to 23.3 percent with the threshold of 70 mg/dL or higher. For those receiving moderate-intensity statins, PCSK9 inhibitor eligibility went up from 1.7 percent with the higher LDL-C threshold to 27.7 percent with the lower threshold. Similarly, for patients receiving any statin, PCSK9 inhibitor eligibility increased from 4.3 percent to 60.6 percent. With the number of patients eligible for PCSK9 inhibitor therapy ranging from approximately 700,000 to 10 million, the researchers conclude there are substantial cost implications associated with PCSK9 inhibitor therapy and suggest a reduction in PCSK9 inhibitor prices to meet cost-effectiveness thresholds. This research was conducted 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. Read more.

NCDR data and news was also previously highlighted. Read more:

• American College of Cardiology, Aga Khan Health Services Partner on First NCDR Registries in the East Africa Region
• American College of Cardiology Announces HeartCARE Center: National Distinction of Excellence Program
• American College of Cardiology Launches NCDR Chest-Pain - MI Registry

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.

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