Safety and efficacy of the new bidirectional rotational Evolution® mechanical lead extraction sheath: results from a multicentre Italian registry.
The aim of this prospective multicentre study is to evaluate safety and efficacy of the new bidirectional rotational mechanical lead extraction (LE) sheath (Evolution RL, Cook Medical, USA) in chronically implanted leads (>1-year-old leads).



Between September 2013 and June 2016, a total of 238 leads in 124 consecutive patients were removed by using the new Evolution RL rotational mechanical sheath. Indications for LE were cardiac device infection in 63 (50.8%) cases, lead malfunction in 41 (33.1%), upgrade in 1 (0.8%) case and for other reasons in the remaining 19 cases (15.3%). Ninety-one leads (38.2%) were implantable cardioverter defibrillator leads (81 dual coil vs. 10 single coil), 38 (16%) right ventricular leads, 86 (36.1%) right atrial leads, and 23 (9.7%) coronary sinus leads. The mean implant duration was 92.2 ± 52.9 months (range 12-336). 91.6% of the leads (218/238) were extracted completely with the Evolution RL alone, with the complete success rate rising to 98.7% (235/238 leads) with combined use of a snare. Overall clinical success rate was 100%. No Evolution sheath-related complications were noted. There were no deaths or major complications. Five minor complications (4%) were encountered. In cases of companion leads no wrapping or lead damage were observed.



On the basis of our prospective multicentre study, the new hand-powered bidirectional rotational mechanical LE sheath is an effective and safe tool for the extraction of chronically implanted leads without major complications and lead wrapping or lead damage.
Department of Cardiology and Cardiothoracic Surgery, Arrhythmia Unit and Electrophysiology Laboratories, Ospedale San Raffaele, Milan, Italy.
Patrizio
P
Mazzone
Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Via N. Giustiniani 2, 35121 Padova, Italy.
Federico
F
Migliore
Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Via N. Giustiniani 2, 35121 Padova, Italy.
Emanuele
E
Bertaglia
University Hospital Santa Maria della Misericordia, Udine, Italy.
Domenico
D
Facchin
University Hospital Santa Maria della Misericordia, Udine, Italy.
Elisabetta
E
Daleffe
Department of Cardiology, Ospedale Civile Ca'Foncello, Treviso, Italy.
Vittorio
V
Calzolari
Department of Cardiology, Ospedale Civile Ca'Foncello, Treviso, Italy.
Martino
M
Crosato
Department of Cardiology and Cardiothoracic Surgery, Arrhythmia Unit and Electrophysiology Laboratories, Ospedale San Raffaele, Milan, Italy.
Francesco
F
Melillo
Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Via N. Giustiniani 2, 35121 Padova, Italy.
Francesco
F
Peruzza
Department of Cardiology and Cardiothoracic Surgery, Arrhythmia Unit and Electrophysiology Laboratories, Ospedale San Raffaele, Milan, Italy.
Alessandra
A
Marzi
Department of Cardiology and Cardiothoracic Surgery, Arrhythmia Unit and Electrophysiology Laboratories, Ospedale San Raffaele, Milan, Italy.
Nicoleta
N
Sora
Department of Cardiology and Cardiothoracic Surgery, Arrhythmia Unit and Electrophysiology Laboratories, Ospedale San Raffaele, Milan, Italy.
Paolo
P
Della Bella
D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D011446:Prospective Studies; D016459:Prosthesis-Related Infections / Q000601:surgery*; D012042:Registries / Q000706:statistics & numerical data; D016896:Treatment Outcome