Cardiac implant registries 2006–2016: a systematic review and summary of global experiences

Abstract

ObjectivesThe importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006–2016) and to provide recommendations on ‘best practice’ approaches.Settings and participantsA systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries.ResultsThe following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis.ConclusionsRegistries provide a ‘real-world’ picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs’ data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate.

Seventeen-year trend (2001–2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups

“…As confirmed by data derived from AIAC Registry [5][6][7][8][9][10][11][12], the rise in ICD utilization was mostly due to the increased number of patients treated for primary prevention. Despite the absolute number of patients with diagnosis of VT/VF (extrapolated by Table 2), increased, the proportion of patients treated for secondary prevention dramatically dropped from 2001 to 2017.…”

“…A review of data collected from 2006 to 2016 by the existing cardiac implant registries was recently published [7]. Completeness is the "ratio between the number of procedures submitted to the Registry and the number of procedures performed in a specific geographical area" [8].…”

Characteristics and Quality of National Cardiac Registries: A Systematic Review

“…Several studies have analyzed registry characteristics for several topics in cardiology, such as percutaneous coronary intervention (PCI), 1 cardiac implant devices, 14 and transcatheter aortic valve implantations. 15 However, no studies have analyzed cardiac registries across the whole cardiac specialty—the aim of this study.…”

Hemodynamically Significant Heart Block After Carotid Artery Stenting in a Patient With Atrial Demand Pacer—Echocardiography-Guided Rescue Pacing

“…The patient's general cardiologist was aware that this surgery was planned and had determined that no programming changes were needed preoperatively. 1 On the day of surgery, the anesthesiology perioperative CIED service interrogated the ICD and found that it was functioning properly. The interrogation also showed that the patient had an underlying sinus bradycardia with an atrial rate of 55 bpm.…”

“…AN INCREASING number of patients are receiving cardiac implantable electronic devices (CIEDs), and many undergo surgical procedures. 1 Surgical procedures involving the carotid artery, while not associated with major fluid shifts, may be associated with hemodynamic instability resulting from the activation of the baroreceptor reflexes, leading to hypotension and bradycardia. Elderly patients are specifically prone to severe hemodynamic perturbations resulting from the activation of the baroreceptor reflex owing to inherent reduction in the stimulation of beta-receptors and replacement fibrosis of their conduction system.…”