DISCUSSION
The number of cardiac implantable electronic device (CIED) implantations
has increased over recent years as a result of population growth, life
expectancy, improving recognition of clinical needs, wider indications,
and better access to healthcare. Lead extractions (LE) have also been
increasing not only as a consequence of this growth, but also because of
increasing rates of infections, lead failures, awareness of indications
for lead management, and development of extraction tools.1. Since time ago, lead removal has been considered a
complex open surgical procedure performed as a last resort and
associated with significant mortality. 2,3Percutaneous approach compared with median sternotomy is an endovascular
intervention more amenable for patients with several comorbidities.
Numerous reports of single and multi-centre TLE experiences have formed
the basis of guidelines for the practice of LE. 4-13
In Argentina, the first TLE was performed in 1993 at the Pirovano
Hospital. 14. Despite long experience,15 Argentina has not had a global and institutional
clinical investigation on real-world patients. This report describes for
the first time the indications, role of the operators, procedures,
different operating environments and safety and effectiveness of
mechanical extraction including tools and techniques. More than 600
procedures were performed over a mean of two years which represent the
reflection of our current practice. The results as detailed above
provide an useful resource for research and improvements in
care.
Patients enrolled in RENEDI had similar demographics characteristics
respect to other TLE studies including age and preponderance of gender.
Lead characteristics (leads types and mean implant time) were also
similar to previous publications. 3,4,10,11 The most
frequent indication for removal was infection but in contrast with other
papers, we had a higher local compromise (isolated pocket infection,
signs of inflammation or erosion) than systemic.5,7,10,11,13 All local manifestations were considered
suspicious of infection although mechanical factors could also be
related. According to consensus document, the whole of them were treated
by complete removal. 17,18
Despite clinical studies have shown that abandoning non-infective leads
is generally safe 19, our results in accordance with
current literature show that removing rather than abandoning
non-functional leads were also preferred. 2,3,10
In contrast with other studies 20,21, vascular and
cardiovascular surgeons were usually the primary operator and operation
theater was the room preferred to achieve these interventions. In almost
20% of cases, procedures were performed by interventional cardiologist
as primary operator. It is relevant to emphasize that presence of
stand-by was desired in 72% (236/325) of the total of TLE. As the
guidelines recommend 1-3, we consider that the
presence of stand-by on site should be highly considered since the
potential for an unexpected cardiovascular complication always exists.
Regarding tools and techniques, simple traction (without the use of any
additional equipment other than a standard stylet) was reported in 25%
of TLE. It is known that this technique is usually effective for leads
with a short dwell time (< 1-2 years). However, in our cohort
study, the mean implant duration was longer than in other similar papers
or guidelines recommendations. 1,7
Our incidence of complications was low. Only one major
complication was reported and no mortality occurred during our study.
Other publications have also demonstrated a similar rate of
complications and low risk of mortality encouraging the performance of
this technique 2,3,7,10, 12.
RENEDI showed a high complete procedural success rate in line with
recent results of RELEASE, PROMET AND ELECTRA database analysis
suggesting that TLE is a safe and efficacy procedure.5,7,10. Comparisons of TLE complications and success
rate in current literature is informed in Table 3 .
Although various issues may impact and influence on successful final
outcomes, we consider that a key factor is the experience and training.
In our registry all physicians were well-trained surgeons and
cardiologists with a vast experience. As for all interventional
procedure, an extensive and high quality learning curve is essential to
become a competent operator in performing these techniques and minimize
the risk of unnecessary and unexpected events. 20,21
This registry is subject to the limitations inherent to observational
studies. The participation in our study was based on a voluntary basis
and no specific protocol or recommendations regarding techniques were
made for TLE procedures as such bias in management strategy could have
existed. Furthermore, follow-up was limited to only hospital discharge.