ACC Registry Data Used to Examine Post-Market Surveillance of ICDs, Stroke Risk in TAVR Patients

NCDR provides data for recent research studies

Contact: Katie Glenn,, 202-375-6472

WASHINGTON (Oct 15, 2018) -

Data from the American College of Cardiology's NCDR was the source of several studies published and presented in recent months, including assessing the use of ICDs in a real-world patient population, post-market surveillance of ICDs, and stroke risk in TAVR patients with carotid artery disease.

NCDR Study Assesses ICD Device Therapy in Real-World Population

Device therapy for patients receiving primary prevention ICDs may vary across demographic and clinical characteristics but may not be significantly different for patients in three subgroups the Centers for Medicare and Medicaid Services (CMS) has identified for further study, according to a study published in the Journal of the American Heart Association. In 2005, CMS issued a "Coverage With Evidence Development" decision that established a national registry of patients receiving primary prevention ICDs to address knowledge gaps in patient selection and clinical decision-making. Three subgroups were identified for further study: patients with left ventricular ejection fraction of 31 percent to 35 percent; those with nonischemic dilated cardiomyopathy of less than nine months; and patients with NYHA class IV heart failure symptoms with a cardiac resynchronization therapy defibrillator (CRT-D). In an effort to assess these subgroups, Robert T. Greenlee, PhD, MPH, et al., used data from ACC's ICD Registry and electronic health records to follow 2,540 patients who underwent ICD implantation between 2006 and 2009 for up to three years. Therapies were classified as appropriate when in response to a potentially malignant ventricular tachyarrhythmia and as inappropriate when attributable to other causes, including supraventricular arrhythmias or problems with device sensing or function. According to the results, 29.1 percent of patients experienced at least one episode that led to a device-related therapy during the median follow-up of 27 months. The researchers classified 55 percent of therapies as appropriate and 30 percent as inappropriate. Read more.

Does Post-Market Surveillance of ICD Detect Only Large Safety Differences?

Small safety differences among ICD generator models may be unlikely to be identified through routine post-market surveillance, but large safety differences may be detected for most patients at anticipated average adverse event rates, according to a study published June 12 in Pharmacoepidemiology and Drug Safety. Jonathan Bates, PhD, et al., used data from ACC's ICD Registry to detect safety differences among different ICD generator models, testing adverse event rates. The data included 100 percent of primary prevention ICD implantations and 80 percent of secondary prevention implantations conducted at U.S. hospitals between 2006 and 2010 and reimbursed by Medicare. According to the results, 141 different ICD models were implanted at least 20 times in a total of 523,529 procedures. The researchers conclude that real-time post-market safety surveillance system would detect safety differences among ICD models for about 90 percent of ICD patients if the safety difference was 50 percent or higher or if the safety event rate was 6.1 per 100 person years or greater. Read more.

NCDR Study Finds No Association Between Carotid Artery Disease, Stroke Risk in TAVR Patients

The presence of carotid artery disease in TAVR patients may not be associated with an increased risk of stroke or mortality at 30 days and one year after undergoing TAVR, according to a study published July 11 in Circulation: Cardiovascular Interventions. Ajar Kochar, MD, et al., looked at 29,143 TAVR patients from 390 U.S. sites enrolled in the STS/ACC TVT Registry. Registry data were linked with Centers for Medicare and Medicaid Services (CMS) claims data to determine 30-day and one-year stroke and mortality outcomes. According to the results, 22 percent of patients had carotid artery disease at the time of the TAVR procedure – 17.2 percent had moderate carotid artery disease, 3.2 percent had severe carotid artery disease and 1.6 percent had occlusive carotid artery disease. Patients with carotid artery disease at baseline were more likely to have a history of hypertension, diabetes, stroke or myocardial infraction. After one year, the primary endpoint of incidence of stroke was 4.5 percent among patients with carotid artery disease vs. 4.1 percent among patients without. A secondary endpoint of all-cause mortality was 21.5 percent for those with carotid artery disease vs. 19.9 percent for those without. Read more.

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

The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As 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 bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit


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