The National ICD Registry Report: Version 2.1 including leads and pediatrics for years 2010 and 2011
Introduction
The evolution of health care toward evidence-driven decision making has been facilitated by electronic data management and the development of large clinical databases. As previously described,1 the American College of Cardiology Foundation (www.acc.org), through its subsidiary the National Cardiovascular Data Registry (NCDR; www.accncdr.com), worked in collaboration with Heart Rhythm Society (HRSonline.org) to develop the National ICD Registry to meet a mandate by the Center for Medicare and Medicaid Services. The registry is a means of determining the degree to which the real-world implantable cardioverter-defibrillator (ICD) use correlates with the randomized trials that inform evidence-based guidelines and to understand the clinical characteristics, processes of care, and outcomes of patients undergoing ICD placement in contemporary clinical practice. A longitudinal substudy of the ICD Registry within the Cardiovascular Research Network is underway to provide insights into longitudinal outcomes, including ICD shocks with a focus on 3 “Coverage with Evidence Development” questions relating to the value of ICDs in patients with ejection fractions between 31% to 35%, patients with heart failure (HF) of 3–9 months’ duration, and patients with New York Heart Association class IV HF.2
Data from version 1 of the registry from the years 2006 to 2009 have been previously published.2, 3, 4, 5 Version 2.1, which has been used since the second quarter of 2010, has clarified and expanded some data elements and deleted others from version 1. The registry also collaborated with the Food and Drug Administration to add lead data fields to version 2.1 as an aid to the process of postmarket lead surveillance. Leads are now tracked in the registry when they are implanted, revised, removed, or abandoned. The Pediatric and Congenital Electrophysiology Society also worked with the registry to include pediatric implants and congenital heart disease diagnoses in the new version. This report details the first 7 quarters of data collection with version 2.1.
General frequency table analyses for categorical variables and univariate analyses for continuous variables were performed among different subcohorts in the data. Chi-square test for categorical variables and t test for continuous variables were used to compare the initial procedures with the procedures with generator change. All the analyses were performed by using SAS software version 9.3 (SAS Institute, Cary, NC).
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Registry overview
At the end of 2011, the ICD Registry had accrued 850,068 ICD procedures (Table 1). In the 7 quarters of data collection using version 2.1, 263,284 procedures performed in 259,395 patients were captured. Hospitals enrolling all their patients in all the 7 reported quarters constituted 67.1% of the participating centers and 86.3% (227,158) of the implants. Hospitals that reported only patients with Medicare primary prevention in each of the 7 reported quarters constituted 12.1% of the
Demographics and clinical data
In the first 7 quarters of version 2.1, recipients of ICD were predominantly white (80.1%) and male (72.5%) (Table 1). The mean age was 67.3±13.0 years, with 347 (0.13%) implants reported in pediatric patients younger than 18 years. Implantation volume by deciles of age is shown in Figure 1. Comorbid conditions including atrial fibrillation, diabetes, hypertension, and symptomatic HF were well represented in the implant population.
Clinician and institutional characteristics
Procedures were performed by more than 4300 clinicians at 1428 institutions during the 7 quarters (Table 2). Most clinicians (54.2%) had electrophysiological training, and combined they performed 83.4% of the procedures. The mean procedural volume per physician during the 7 quarters was 60.0, with a median of 32. The annual average was 38, or about 3 per month per physician, and the median annual volume was 22 (calculated as quarterly volume multiplied by 4 when less than a full year’s data
ICD use
ICDs were implanted for a primary prevention indication in 73.8% and a secondary prevention indication in 22.5% in the first 7 quarters by using version 2.1 (Table 3, Table 4). “Lead-only” procedures were performed in 9855 (3.7%). Single-chamber, dual-chamber, and cardiac resynchronization therapy (CRT) devices were implanted in about 18%, 36%, and 42% of the patients, respectively. New device implants accounted for 56.5% and 39.8% were generator replacement. Upgrades (6.5% of all procedures
Lead data
During these 7 quarters, there were 561,692 leads entered into the database, of which 57.6% were new and 42.4% were previously implanted (Table 5). Preexisting lead function was abnormal in 16,797 (7.0%), and 14,267 (6.0%) were under advisory. Pace/sense problems were more frequent than defibrillation issues (3.5% vs 1.5%). Of the preexisting leads, the majority of leads (85.5%) were reused and an equal percentage of leads were extracted (7.2%) or abandoned (7.3%). Because lead data are
Complications
Relative to all procedure types, any adverse event occurred in 2.2% of all operations and death or a major adverse event (cardiac arrest, hemothorax, pericardial tamponade, urgent cardiac surgery, myocardial infarction, cerebral vascular accident or transient ischemic attack, pneumothorax, cardiac perforation, or set screw problem) occurred in 1.56% (Table 6). Infection leading to reoperation occurred in 1.47%. The incidence of death was 0.31%. Intraprocedural death was 0.02% and unchanged from
Therapy delivery
ICD programming is not controlled in the registry, as it is at the discretion of the clinicians. Programmed parameters including the cycle length and number of intervals to meet tachyarrhythmia detection will potentially impact both the delivery of therapy and its appropriateness. Moreover, the registry does not collect longitudinal data on ICD therapies. However, among patients undergoing device replacement, summary data on previous therapy delivery are collected. These data are not detailed
Discussion
The ICD Registry is a valuable resource that provides important insights into clinical and procedural characteristics of patients receiving an ICD in the United States. It is also a resource that continues to evolve and mature. While registry data have been the basis for multiple important manuscripts about ICD use,6, 7, 8, 9, 10, 11 it is important to acknowledge that the registry data are not the result of a controlled clinical trial and reflects an attempt to balance the requirements and
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This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR).
ICD Registry is an initiative of the American College of Cardiology Foundation and the Heart Rhythm Society.