Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome

Abstract

Background: In addition to the Evolution RL sheath, tools by Cook Medical (Bloomington, IN, USA), supporting lead extraction (LE), are available. Data on their use are not reported in detail in previous studies. Moreover, data regarding outcome are lacking. The aim was to evaluate the safety and effectiveness of the Evolution sheath (Evolution RL and Evolution Shortie, Cook Medical) by using a stepwise approach with the available extraction tools and the outcome. Methods:A total of 393 leads in 198 consecutive patients were removed with the Evolution RL sheath and ancillary tools using a stepwise approach.Results: The main indication for LE was infection in 125 (63.1%) cases. The mean implant duration was 95.4 ± 59.7 months. According to our stepwise approach, the Evolution Shortie RL sheath was used in all cases and complete LE was achieved in 24 (12.2%) cases. The Evolution RL was used in 174 (87.8%) cases and the SteadySheath Evolution tissue stabilization sheath (Cook Medical) in 87 (44%) because of tenacious fibrosis anchored targeted leads. Compression coil (OneTie, Cook Medical) was used in 141 (71%) cases. Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 97%, 99%, and 99.5%, respectively. One major complication (0.5%) and 10 (5%) minor complications were encountered. During a mean time follow-up of 12 ± 9 months, 14 (7%) patients died. Predictors of mortality included impaired renal function (HR 5.7; 95% CI 1.9-17.6; P = 0.002), extraction because of infection (hazard ratio [HR] 4.0; 95% confidence interval [CI] 1-18.1; P = 0.045), and diabetes (HR 3.2; 95% CI 1.1-9.8; P = 0.036). Conclusions:Lead extraction using the Evolution RL bidirectional rotational mechanical sheath and ancillary tools in a systematic stepwise approach was effective and safe. K E Y W O R D S cardiovascular implantable electronic device, Evolution RL rotational sheath, infection, mortality, transvenous lead extraction Pacing Clin Electrophysiol. 2019;42:989-997.

Use of the new rotating dilator sheath TightRail™ for lead extraction: A bicentric experience

“…To address this issue many extraction techniques have been developed including laser sheaths, mechanical sheaths, or electrosurgical dissection sheaths . A bidirectional rotational mechanical sheath (Evolution RL, Cook medical) has proved to be extremely safe and effective with long implanted leads . However, powered sheaths have been related to higher complication rates, and concerns can be raised about their use in case of recently implanted leads.…”

“…[4][5][6][7] A bidirectional rotational mechanical sheath (Evolution RL, Cook medical) has proved to be extremely safe and effective with long implanted leads. 8,9 However, powered sheaths have been related to higher complication rates, 2 and concerns can be raised about their use in case of recently implanted leads. The treated metal distal tip of Evolution RL allows the system to pass through adhesions but could also damage surrounding tissue.…”

Subcutaneous Implantable Cardioverter Defibrillator and LifeVest Saving Lives in Challenging Scenarios

“…In the second case, the generator and lead were bacteria-free, likely because of the broad-spectrum antimicrobial therapy started 3 days before the system explantation. Of note, infections are the main cause of ICD generator and lead extraction [5]. The incidence of device infections varies from 0.5 to 2.2%, with a 6% mortality rate in two years.…”

“…The increasing number of implantation procedures leads to a growth of related complications, as pocket or lead infections, endocarditis or even septic shock [4]. The treatment of choice for these infections is the removal of the entire system, together with antimicrobial therapy [5]. These patients, after recovering, maintain a high infective risk, together with the need for persistent ICD protection.…”

Successful jugular implantable defibrillator lead extraction with bidirectional rotational mechanical sheath

“…Manual traction was attempted unsuccessfully with a locking stylet. The lead was successful extracted with powered‐mechanical sheath and outer sheath using a step wise approach 1 (first using Evolution Shortie RL 11F and then Evolution RL 11F, Cook Medical, Bloomington, IN, USA) through the jugular vein (Figure 1C‐F) Multiple adhesions were found in the entry vein site, in the brachiocephalic vein, and superior vena cava. No complications were encountered during and after the procedure.…”