A new bidirectional rotational mechanical lead extraction sheath is both safe and effective in performing lead extraction, according to a study published online ahead-of-print in Europace. Clinical success for the leads extracted using this novel sheath was 98.1% with no mortality or major complications.
Christoph T Starck, German Heart Institute of Berlin, Berlin, Germany, and colleagues write that, “especially in long implanted leads,” transvenous lead extraction procedures can be “very challenging”. As the difficulty of an extraction increases, the risk of complications can also be expected to rise. “Transvenous lead extraction procedures can lead to serious, life-threatening complications in rare circumstances,” the authors write, and thus “safety issues should be of central concern in lead extractions.”
The ideal extraction device should “combine a maximum of patient safety with high success rates,” Starck and colleagues suggest. In this study, the authors were investigating the second generation of the Evolution device from Cook Medical, the Evolution RL rotational sheath, which, according to them, improves on the first generation with a less aggressive tip and a bidirectional mechanism, designed to eliminate lead wrapping and insulation damage of adjacent leads.
From April 2013 to September 2014, the researchers performed lead extraction procedures in 71 patients (50 males, 21 female) with 112 leads (73 pacemaker leads, 39 implantable cardioverter-defibrillator leads) scheduled for extraction. During this time period, the Evolution RL rotational sheath was used in 40 patients to extract 52 leads (24 pacemaker leads and 28 implantable cardioverter-defibrillator leads). Success was defined as either clinical or complete procedural success according to the definitions of the Hearth Rhythm Society. The mean lead implant duration in these patients was 100.2 (ranging from 22–271) months. Forty leads were right ventricular leads, 10 were right atrial leads, and two were coronary sinus leads.
Starck et al report clinical success and procedural success rates for the leads approached with the Evolution RL device of 98.1% and 88.5%, respectively. Clinical and complete procedural success for the entire patient cohort was 99.1% and 93.8%, respectively. For the Evolution RL device, partial success was reported in five cases and procedural failure in one. For all five partial successes, “it was merely the anchor tip of long implanted passive fixation pacemaker leads that remained in situ.” The absence of total procedural success was attributed to a mean lead implant of more than 12 years, as “it is well known that lead implant durations of more than 10 years are a predictor for incomplete extraction or failure,” explain the authors. Operative mortality was zero and no major complications occurred. There were four minor complications, all of which were pocket haematomas requiring drainage. No device-related complications were reported. In cases with multiple leads in situ, no wrapping of companion leads was seen, which was a recurring problem with the first generation of the device. The average number of extraction tools used per lead was 2.4 (ranging from 2–4) in the Evolution RL cohort.
“Our presented results of the Evolution RL device showed no device-related complications, especially no injuries to vascular structures, the tricuspid valve or myocardium,” write Starck and colleagues. Although the results “have to be interpreted under the light of the still relatively small number of leads treated and they need to be re-evaluated as soon as larger study populations are available,” they are encouraging given the need for “an excellence safety performance” in transvenous lead extraction devices.
Starck told Cardiac Rhythm News that those patients with long implanted leads which show strong fibrotic adhesions, especially in the critical region of the superior vena cava, benefit most from the Evolution RL rotational sheath.