Discussion
During the last two decades, the number of CIEDs implanted has increased steadily as technological advances have allowed a wider range of conditions to be treated with implantable devices. Moreover, the number of dual chamber vs single chamber pacemakers, along with the use of cardiac resynchronization devices has also increased (9-12). As such, not only has the number of CIED implantations but also the number of implanted leads has increased. This has led to a higher number of lead related complications, mainly infection, and a greater number of TLE procedures performed.
This is the first Latin American survey on TLE. Although smaller than previous surveys (13-15), answers were received from 48 respondents from 44 different institutions (8 different countries). As such the survey provides valuable information on the current practice of lead extraction in our continent. Importantly, although TLE is performed in several institutions in Latin America, most (66%) report a low procedural volume (i.e., less than 10 procedures per year). This percentage is higher than that reported in the US (in which less than 20% of institutions performed <10 lead extraction procedures per year) and the first European lead extraction survey (in which 40% of institutions performed <10 procedures each year)(15) demonstrating a low use of TLE in the continent. Several possible reasons exist for this finding: high cost of lead extraction tools, a perceived higher risk for complications (as evidenced by a reluctance to perform TLE in patients older than 80 years old in 22% of respondents), and a lack of proper training/knowledge (16). Unfortunately, the number of implant procedures and the infection rate in Latin America is currently unknown but taking into consideration European guidelines which estimate the need of TLE as 1.5 times the infection rate (17), a significantly higher number of lead extraction procedures is expected. Lack of public financing in many Latin American countries has a significant impact on CIED use and waiting times (18), and as such should also impact the use of TLE techniques. Implementation of training programs, along with a reduction in costs associated with TLE tools could have positive impact on the number of lead extraction cases performed. Taking into consideration that low procedural volume (defined in the ELECTRa registry as less than 30 lead extraction procedures per year) is associated with a significant increase in procedural mortality, efforts should be made to increase training and to perform lead extraction procedures only in high volume centers (19).
Although most institutions (73%) used mechanical rotating sheaths (which is similar to what was found in the European survey)(13), 13.5% of institutions reported the use of laser sheaths. This is particularly surprising in latin america, taking into consideration the higher cost of laser sheaths (20), with procedural success rates similar to those reported with current mechanical rotating sheaths (21-23). In fact, in the recently published PROMET study laser sheaths were almost entirely abandoned in favor of mechanical rotating sheaths due to lower costs and similar effectiveness (24). Regarding safety measures, cardiac surgeons were included (either in room or within the institution) by 92% of respondents, similar to what has been described in the ILEEM survey (25) but higher than reported in the US survey (in which a surgeon was not identified in 25% of lead extraction procedures)(14). Importantly, other safety measures including TEE (39%) ICE (16.2%) and the BRIDGE balloon (13.5%) were used in a significant number of institutions.
Regarding the proposed clinical scenarios, the number of respondents who perform complete capsulectomy in CIED related infection is lower than that reported in a recent worldwide survey (57% vs 76%)(26). This is in line with the most recent guidelines, in which capsulectomy is not recommended as routine practice (27). Elderly patients (i.e., those older than 80 years of age) were considered to be at high risk of procedure related complications and 24% of respondents routinely avoided extraction in this patient population. Indeed, extraction procedures in elderly patients have been found to be significantly associated with a higher periprocedural mortality (2.5% in 18–44 years compared to 5.3% in 85+ years, P < 0.001) in the US (28). Finally, regarding malfunctioning leads, 71% of respondents would base their decision (i.e., lead abandonment or extraction) on individual patient characteristics. This is similar to what has been described in previous European surveys, in which malfunctioning lead management was strongly determined by patient’s age, the presence of damaged leads and lead dwelling time (29).
Recently, the results of the largest prospective lead extraction registry in Latin America were published, demonstrating the safety and effectiveness of lead extraction in a large volume center (30). Future efforts should thus be focused on increasing the number of centers performing high volume lead extraction, as this study demonstrates results comparable to those published in literature can be achieved.