Key result
The bidirectional R/L type Evolution mechanical sheath achieved a higher complete procedural success rate for lead extraction compared to the original unidirectional sheath.
Why the study?
Does the Evolution mechanical sheath safely and effectively extract chronic pacemaker and ICD leads in patients requiring lead extraction?
Observational (n=77)
Does the Evolution mechanical sheath safely and effectively extract chronic pacemaker and ICD leads in patients requiring lead extraction?
The Evolution mechanical sheath is a safe and effective tool for chronic lead extraction, with the bidirectional R/L type demonstrating superior complete procedural success compared to the original unidirectional sheath.
Answers are grounded in this paper and cite their sources.
Bidirectional sheath associated with higher extraction success; leaves open need for randomized confirmation before practice change.
AIMS: The Evolution sheath (Cook, USA) is a power sheath with a cutting screw tip operated by mechanical rotation. It has been reported to be an effective tool for chronic lead extraction. We evaluated the safety and efficacy of this system. METHODS AND RESULTS: From 2009 to 2014, all lead extractions requiring the use of an Evolution sheath were prospectively examined. In 77 patients, 111 leads were extracted. The first 57 leads were extracted with the original unidirectional sheath, and since 2013, 54 leads were extracted with the bidirectional R/L type. According to the current guidelines, complete procedural success was defined as the removal of all targeted lead material. 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 111 leads in 77 patients. The median age of the lead at time of extraction was 8.0 years (median 6.9, interquartile range 6.4, minimum: 0.6 and maximum: 34.4), with a clinical success rate of 98% and a complete procedural success of 88%. Complete procedural success was higher for the R/L type Evolution sheath (96 vs. 80%, P = 0.006). There were 21 (19%) implantable cardioverter defibrillator leads, 22 (20%) right ventricular pacing leads, 60 (54%) right atrial leads, and 8 (7%) left ventricular leads. There were no major complications and six (8%) minor complications. There was no need for the usage of a femoral tool or snares. CONCLUSION: Use of Evolution for lead extractions seems to be safe and effective, with a high clinical success rate.
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Delnoy et al. (2015) conducted an observational in Chronic lead extraction (n=77). Bidirectional R/L type Evolution mechanical sheath vs. Original unidirectional Evolution sheath was evaluated on Complete procedural success (removal of all targeted lead material) (p=0.006). The bidirectional R/L type Evolution mechanical sheath achieved a higher complete procedural success rate for lead extraction compared to the original unidirectional sheath.
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