ELECTRa (European Lead Extraction ConTRolled) Registry--shedding light on transvenous lead extraction real-world practice in Europe.
With the growing recognition of the clinical need and wider indications for cardiovascular implantable electronic devices (CIED), the number of implant procedures has increased considerably. Consequently, the rate of complications related to these devices has also increased. Transvenous lead extraction (TLE) is the gold standard in the treatment of CIED-related infective complications and is often required in the management of lead malfunction. An increasing number of centers currently perform TLE procedures. The ELECTRa (European Lead Extraction ConTRolled) Registry is the first large prospective multicenter registry of consecutive patients undergoing TLE in Europe, conducted by the European Heart Rhythm Association (EHRA) and managed by the European Society of Cardiology (ESC) EURObservational Research Department. The primary objective of the registry is to evaluate the acute and long-term safety of TLE; the secondary objective is to describe the characteristics of the patients, the leads, the indications for TLE, and the tools and techniques currently used for TLE. About 100 centers will be enrolled on a voluntary basis from European countries; they are anonymous and stratified on the basis of their volume of activity into high-volume centers (>30 patients/year) and low-volume centers: (≤30 patients/year). Each participating center will have to enroll and follow up for 1 year consecutively assessed patients undergoing TLE from November 2012 to January 2014. The target is to achieve a sample size of at least 3,500 patients for statistical analysis. Data will be collected using a Web-based system and will be audited at randomly selected centers. The official start was on 6 November. Eighty-nine centers have joined so far, 65 centers are currently active, those who have already obtained the approval of their own ethics committee, and 1,099 patients were enrolled at the end of June 2013. The independence of the registry, the consecutiveness of the patient enrolment, and the monitoring of the study are characteristics of this registry that will contribute to the scientific validity of the objectives to be achieved.
Second Cardiology Department, Santa Chiara University Hospital, Paradisa Street 2, 56100, Pisa, Italy. m.g.bongiorni@med.unipi.it
Maria Grazia
MG
Bongiorni
Simone L
SL
Romano
Charles
C
Kennergren
Christian
C
Butter
Jean Claude
JC
Deharo
Andrzej
A
Kutarsky
Christopher Aldo
CA
Rinaldi
Aldo P
AP
Maggioni
Carina
C
Blomström-Lundqvist
Angelo
A
Auricchio
D016757:Death, Sudden, Cardiac / Q000453:epidemiology* / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D020878:Device Removal / Q000706:statistics & numerical data*; D005060:Europe / Q000453:epidemiology; D006801:Humans; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D015995:Prevalence; D016459:Prosthesis-Related Infections / Q000453:epidemiology*; D012042:Registries / Q000706:statistics & numerical data*; D016896:Treatment Outcome