Success and complication rates of lead extraction with the first- vs. the second-generation Evolution mechanical sheath.
OBJECTIVE
The Evolution sheath (Cook Medical, USA) is a power sheath frequently used for chronic lead extraction. In 2013, a novel type (bidirectional) of Evolution sheath (the RL type) was introduced. We evaluated differences in success and complication rates of the two types.


RESULTS
From 2009 to 2015, all lead extractions requiring the use of an Evolution sheath were prospectively examined. According to the current guidelines, complete procedural success was defined as the removal of all targeted lead materials. Clinical success was the retention of a small portion of the lead, and failure was the inability to achieve either complete procedural or clinical success or the development of any permanently disabling complication. The Evolution sheath was used to extract 149 leads in 103 patients. The first 56 leads were extracted with the original unidirectional sheath, and 93 leads were extracted with the novel bidirectional R/L type. The median age of the lead at the time of extraction was 6.8 vs. 9.1 years (P = 0.007). Complete procedural success was higher for the Evolution R/L (80.0 vs. 98%, P = 0.0004). Clinical success rate was 98 vs. 99%. There were no major complications and 6 (12.0%) vs. 2 (3.8%) minor complications (P = 0.153). We did not observe changes in success rates or complications over time, meaning that the difference cannot be explained by learning curve.


CONCLUSIONS
Use of the novel Evolution R/L sheath vs. the original Evolution sheath was associated with significant higher complete success rates, without major complications and with a trend towards the reduction of minor complications.
Department of Cardiology, Isala Heart Centre, Dr. Van Heesweg 2, 8025 AB Zwolle, The Netherlands.
Olivier A
OA
Witte
Department of Cardiology, Isala Heart Centre, Dr. Van Heesweg 2, 8025 AB Zwolle, The Netherlands.
Ahmet
A
Adiyaman
Department of Cardiology, Isala Heart Centre, Dr. Van Heesweg 2, 8025 AB Zwolle, The Netherlands.
Jaap Jan J
JJJ
Smit
Department of Cardiology, Isala Heart Centre, Dr. Van Heesweg 2, 8025 AB Zwolle, The Netherlands.
Anand R
AR
Ramdat Misier
Department of Cardiology, Isala Heart Centre, Dr. Van Heesweg 2, 8025 AB Zwolle, The Netherlands.
Arif
A
Elvan
Department of Cardiology, Isala Heart Centre, Dr. Van Heesweg 2, 8025 AB Zwolle, The Netherlands.
Abdul
A
Ghani
Department of Cardiology, Isala Heart Centre, Dr. Van Heesweg 2, 8025 AB Zwolle, The Netherlands.
Peter Paul H M
PPHM
Delnoy
D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D017147:Defibrillators, Implantable / Q000009:adverse effects; D020878:Device Removal / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
Complications; Implantable cardioverter-defibrillator; Lead extraction; Pacemaker