ACC Registry Data Used to Examine Device Safety, Valve Replacement Outcomes

National Cardiovascular Data Registry provides data for published research studies

Contact: Katie Glenn, kglenn@acc.org, 202-375-6472

WASHINGTON (Apr 14, 2017) -

The American College of Cardiology's National Cardiovascular Data Registry was the source of data for several manuscripts published in early 2017, including a study examining vascular-closure device safety, the ACC's Patient Navigator Program and an initiative to compare real-world patient outcomes to findings from recent clinical trials.

NCDR Study Looks at Safety of Vascular-Closure Device

Among patients who undergo a percutaneous coronary intervention (PCI) procedure with femoral access, the risk of a vascular complication may be higher with the Mynx vascular-closure device compared to other vascular-closure devices, according to a study published Jan. 25 in the New England Journal of Medicine. The study, led by Frederic S. Resnic, MD, FACC, was designed to assess the postmarketing safety of the Mynx device and looked at data from the 73,124 patients enrolled in the ACC's CathPCI Registry who received the device from January 2011 to September 2013. Results showed that the Mynx device was associated with a "significantly greater risk" of the primary outcome of any vascular complication—a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding or any vascular complication requiring intervention—as compared to other devices. There was also a "significantly greater risk" of the secondary safety endpoints: access-site bleeding requiring treatment and postprocedural blood transfusion. However, the authors note that the absolute risk differences were small. Read more.

NCDR.17 Research Explores Success of ACC's Patient Navigator Program

New research exploring heart failure (HF) education processes, post-discharge phone calls, scheduled follow-up appointments and readmission rates were presented as poster abstracts during NCDR.17 in National Harbor, Maryland. Read more.

New Research Using NCDR Data Highlights Real-World Impacts of Clinical Trial Findings

New research presented at ACC.17 is using data from ACC's PINNACLE Registry to compare real-world patient outcomes to findings from recent clinical trials. The studies are part of ACC's Research to Practice (R2P) initiative, which identifies impactful cardiovascular research and analyzes its implications for contemporary clinical practice using ACC's NCDR clinical registries. Two abstracts are being presented as part of ACC.17, while one study was recently published in the American Journal of Cardiology. Read more.

NCDR Data Compare Real-World Outcomes of Valve-in-Valve and Native Valve TAVR

Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) was found to be safer than native valve (NV) TAVR, according to research presented by E. Murat Tuzcu, MD, FACC, on March 18 at ACC.17 in Washington. According to the study, ViV TAVR could be a safe and effective option for patients with failed surgical aortic valve replacement (SAVR). Study investigators compared 757 ViV TAVR patients and 28,895 NV TAVR patients within the NCDR STS/ACC TVT registry—enrolled between November 2011 to September 2015—who had one-year outcome data linked to Medicare administrative claims. The ViV TAVR patient group had a median age of 79 years and 39 percent were women, while the NV TAVR patient group had a median age of 84 years and 46 percent were women. In the ViV TAVR group compared with the NV TAVR group, in-hospital mortality was lower (2.3 percent vs 4.1 percent) as well as one-year mortality (13.3 percent vs 23.1 percent). Similarly, the rates of stroke were lower with ViV TAVR both in-hospital (0.04 percent vs 2.1 percent) and at one year (2 percent vs 4.3 percent). Read more.

NCDR Registry Data Provides Insights on MitraClip Outcomes in U.S.

Data from the NCDR STS/ACC TVT Registry revealed a high rate of acute procedural success with the MitraClip system for transcatheter mitral valve (MV) repair, according to results presented by Paul Sorajja, MD, FACC, on March 18 at ACC.17 in Washington, DC. In 2,952 patients examined for the acute outcome, 92.8 percent had post-procedural mitral regurgitation of ≤2. In-hospital mortality was 2.7 percent, and most patients were discharged home (85.9 percent) after a median two-day hospitalization. The median age of the patients was 82 years, 56 percent were men, 85 percent had NYHA Class III/IV heart failure and 93 percent had Grade III/IV mitral regurgitation. The study investigators analyzed data in patients enrolled in the TVT Registry between December 2012 and September 2015. To evaluate longer term outcomes in these patients, they examined Centers for Medicare and Medicaid Services claims data in 1,867 of these patients. At one year, 25.9 percent of patients had died, 20.2 percent were re-hospitalized for heart failure and 37.9 percent had experienced either event. A repeat MitraClip procedure was required in 6.2 percent and 2.1 percent required MV surgery. Read more.

NCDR data was also used in studies previously highlighted during this time period. Read more:

Radial Access, Same-Day Cardiac Procedure Could Save $300 Million Annually

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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