Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques

Abstract

<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Aims</jats:title> <jats:p>Several large studies have documented the outcome of transvenous lead extraction (TLE), focusing on laser and mechanical methods. To date there has been no large series addressing the results obtained with rotational lead extraction tools. This retrospective multicentre study was designed to investigate the outcomes of mechanical and rotational techniques.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and results</jats:title> <jats:p>Data were collected on a total of 2205 patients (age 66.0 ± 15.7 years) with 3849 leads targeted for extraction in six European lead extraction centres. The commonest indication was infection (46%). The targeted leads included 2879 pacemaker leads (74.8%), 949 implantable cardioverter-defibrillator leads (24.6%), and 21 leads for which details were unknown; 46.6% of leads were passive fixation leads. The median lead dwell time was 74 months [interquartile range (IQR) 41–112]. Clinical success was obtained in 97.0% of procedures, and complete extraction was achieved for 96.5% of leads. Major complications occurred in 22/2205 procedures (1%), with a peri-operative or procedure-related mortality rate of 4/2205 (0.18%). Minor complications occurred in 3.1% of procedures. A total of 1552 leads (in 992 patients) with a median dwell time of 106 months (IQR 66–145) were extracted using the Evolution rotational TLE tool. In this subgroup, complete success was obtained for 95.2% of leads with a procedural mortality rate of 0.4%.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>Patient outcomes in the PROMET study compare favourably with other large TLE trials, underlining the capability of rotational TLE tools and techniques to match laser methods in efficacy and surpass them in safety.</jats:p> </jats:sec>

Comparison of acute and long‐term outcomes of Evolution® and TightRail™ mechanical dilator sheaths during transvenous lead extraction

“…Evolution ® system has been associated with excellent clinical and procedural success with low complication rates in previous studies. [9][10][11] In our study, complete clinical success and procedural successes were 99.2% and 94.0%, respectively, as in other studies, complete clinical and procedural success rates have been mostly >95%. 8,11 The clinical and procedural success rates were 88.0% and 84.2% without using rescue methods in our study.…”

Efficacy and safety of transvenous lead extraction using a liberal combined superior and femoral approach

“…Our TLE outcome was also comparable to a recently published European registry, the PROMET (Patient-Related Outcomes of Mechanical lead Extraction Techniques) study, which was focused on the use of rotational TLE tools in 6 high-volume centers [22]. In the PROMET study, clinical success was obtained in [23].…”

Safety and efficacy of transvenous lead extraction in octogenarians using powered extraction sheaths

“…Furthermore, our results are comparable to previously published studies using mechanical rotational sheaths. The reported major complication rates were between 0% and 1.5% 23–26 . Despite the advanced age of our patient population and the long lead dwell time, the procedure was safe, with comparable complication rates to younger populations.…”

“…Procedural success rates, ranging between 90% and 100% 7–11 have been described in previously published laser lead extraction studies analyzing younger populations. Studies using mechanical rotational sheaths have reported procedural success rates between 80% and 98.3% 23–26 …”