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.