Lead extractions: dissecting adhesions up to the lead-tip of the right ventricle: safety and success-rates.

AIMS: Goal of Transvenous Lead Extraction (TLE) is complete removal of all targeted leads, without complications. Despite counter traction manoeuvres, efficacy rates are often hampered by broken right ventricle lead (RV-lead) tips. Mechanically powered lead extraction (Evolution sheath) is effective, however safety of dissection up to the lead tip is unclear. Therefore, we examined the feasibility and safety of RV-lead extraction requiring dissection up to the myocardium. METHODS AND RESULTS: From 2009 to 2018, all TLE in the Isala Heart Centre (Zwolle, The Netherlands) requiring the hand-powered mechanical Evolution system to extract RV-leads (n = 185) were examined from a prospective registry. We assessed 4 groups: TLE with the first generation Evolution (n = 43) with (A1,n = 18) and without (A2,n = 25) adhesions up to the myocardium and TLE with the Novel R/L type (n = 142) of sheath with (B1, n = 59) and without (B2, n = 83) adhesions up to the myocardium. Complete success rate in Group B was significantly higher than group A (96.5 vs 76.7%, p = 0.0354). When comparing the patients with adhesions up to the myocardium, total complete success is higher in the R/L group (61.1% vs 90.5%, p = 0.0067). There were no deaths. Overall major complication rates were low (2/185; 1.1%) and there was no statistically significant difference in major and minor complications between the two groups. CONCLUSION: Extraction strategy with the bidirectional Evolution R/L sheath for right ventricular leads with adhesions up to the myocardium is safe and feasible.

Mechanical power sheath mediated recanalization and lead implantation in patients with venous occlusion: Technique and results.

INTRODUCTION: Chronic venous occlusion hampers lead revisions and upgrades in patients with a cardiac implantable electronic devices (CIEDs). This can make cardiothoracic surgery, venoplasty, or contra-lateral implantation of leads with tunneling necessary. A technique using venous recanalization may be a preferred alternative. We assessed the efficacy and safety of this new technique. METHODS AND RESULTS: From 2009 to 2016, all consecutive patients planned for lead revision or upgrade with known chronic venous occlusion were studied. All patients underwent extraction of an existing malfunctional or functional CIED lead with the Cook Evolution mechanical power sheath. By using the lumen of the sheath, endovascular access to the heart was obtained for new leads. Forty-two patients (107 leads, 2.6 ± 1.1) were included. The indication for this procedure was replacement of malfunctional leads (n = 35, 83%) or device upgrade (n = 7, 17%). In total, 77 leads were extracted (30 leads stayed in situ) with a mean age at time of extraction of 8.4 years. Because of damage to bystander leads during extraction, two additional leads (one RA lead, one LV lead) were extracted. Clinical success was achieved in 41 patients (97%) and complete success in 39 patients (93%). There were two minor complications (two pocket hematomas, managed conservatively) and one major complication (tamponade, needing thoracotomy). Mean procedure time was 3.0 hours (median, 2.0; range, 1:28-5:35 hours) with a mean fluoroscopy time of 14.9 ± 12.5 minutes. CONCLUSIONS: The technique of Evolution-mediated recanalization in case of lead revisions or upgrades is feasible with an acceptable safety profile and high efficacy.

Success and complication rates of lead extraction with the first- vs. the second-generation Evolution mechanical sheath.

AIMS: 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. METHODS AND 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. CONCLUSION: 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.

Lead extractions: the Zwolle experience with the Evolution mechanical sheath.

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.