Endpoints were classified according to the guidelines [1, 4]. Complete procedural success was defined as the removal of all targeted leads from the vascular space, without any permanently disabling complications or procedure-related deaths. Clinical success in cases in which a small portion of the lead (less than 4 cm) remained in a vascular space and is not detrimental to the clinical outcome. Failure was defined as the inability to achieve either complete procedural or clinical success, or the occurrence of a major complication or procedure-related death.

Statistical analysis

Continuous variables are expressed as median values and 1st and 3rd quartiles (Q1–Q3) and categorical data are reported as frequencies and percentages. Statistics were completed using Statistica 13 software (Statistica, TIBCO Software Inc., Palo Alto, California, USA). The groups were compared using the Mann–Witney U test (W Shapiro–Wilk test showed non-normally distributed data), and a P <0.05 was considered to be significant.

RESULTS AND DISCUSSION

Laser-assisted lead extraction procedures were performed in 33 patients (24 men) at a median age of 64 years (57–74). We attempted to remove 49 leads. Detailed patient, lead and device characteristics are described in Table S1 and Table S2 in Supplementary material. Indications for lead extraction were: lead failure (15 [45.5%]), pocket infection (9 [27.3%]), cardiac device-related infective endocarditis (CDRIE) (5 [15.2%]), elective lead replacement (2 [6%]), and dislocation of the lead (2 [6%]).

Clinical success was achieved in 31 (94%) patients, whereas complete lead removal was achieved in 92% of lead extraction (45 leads). Complete procedural success appeared in 30 (91%) patients. TLE failure occurred in 3 patients with a dual-chamber pacemaker and was caused by inability to remove targeted leads from the vascular space in 2 cases and procedure-related death in 1 case. As a result, we noticed 4 failures of lead extraction (8%) in 3 patients. The mean lead dwell time of the failed extraction leads was 13.6 years (163 months [9–17 months]). The clinical success of the first 2 cases was confirmed during follow-up, and overall clinical success was 97% (32 out of 33 patients).

In-hospital complications related to procedure were divided, according to guidelines, into major (including death in 1 [3%] patient and cardiac avulsion in 2 [6%] patients) and minor (pericardial effusion not requiring surgical intervention in 2 [6%] patients and blood transfusion related to blood loss during surgery in 1 [3%] patient) [1, 4].

In 4 cases, a second procedure in the same patient was necessary to achieve procedural success, and in one situation, surgical removal of the lead was necessary.

It is worth noting that the last 9 out of all patients who underwent LALE did not have any complications. Those procedures were performed after purchase of the laboratory’s own laser generator and after implementing the rule that a laser sheath was used only if the locking stylets reached the tip of the lead. Another factor that could have influenced that observation was the team’s experience which had increased since the first use of LALE procedures.

During the follow-up, 11 out-of-hospital deaths were reported. There were three deaths between first and twelfth months after the procedure. The median time of death after 1 year was 53 months (range, from 17 to 86 months).

We performed an analysis of all-cause mortality, and the patients who died were older and had higher creatinine levels (Table 1).

The demographics, lead data, groups of indications for TLE are mostly comparable with other studies; however, there were some differences, for example the number of patients with pacemakers (45.4% vs 70%) [5, 6]. Also proportions of certain indications were different. In our study, the main indication for TLE was lead failure. The ELECTRa registry shows the same frequency of infectious and noninfectious indications in Europe [7]. Similarly, in the study by Ząbek et al. [8], both CDRIE and pocket infection together did not account for 20% of TLE indications.

In our study, the clinical success was achieved in 94% of cases, while Kennergren et al. [6] achieved an efficacy of 97.6% leads. Wazni et al. [9] described efficacy of 92.2% in operated patients, while Byrd et al. [10] reported complete success in 90% of leads. In our study, the mean lead dwell time was 150 months. In other studies it was much shorter, e.g. 91 months [6]. Byrd et al. [10] observed that removal of lead implanted more than 10 years prior to the procedure was a predictor of procedural failure. Kennegren et al. [6] also reported that a longer time from implantation to removal was associated with a higher incidence of procedure failure, although it did not reach a level of statistical significance.

In the presented study the rate of major complications was 6%, while in other studies it ranged from 4% in the Wazni et al. [9] study, through 2.5% in the laser group in the PLEXES trial [11], through 2.1% in the Byrd et al. [10] study, to 1.7% in the ELECTRa Registry [7].

The analysis of all-cause mortality shows that older age and a higher creatinine level are predictors of a worse outcome of TLE. This result is similar to the study by Brunner et al. [12]. Also Jacheć et al. [13] demonstrated that heart failure, chronic kidney disease, and pacemaker infections together with minor complications influenced 30-day mortality.

CONCLUSIONS

It is unlikely to prove that introducing new procedures like the new method of lead extraction is safe and effective. The implementation of new surgical methods should be initiated in centers that are already highly experienced, and which initiate contemporary practice. It is important to apply a risk-benefit analysis, especially in patients with class II TLE indications, taking into consideration risk factors such as older age and kidney impairment, which are proven to worsen outcomes of patients after TLE.

Supplementary material

Supplementary material is available at https://journals.viamedica.pl/kardiologia_polska.

Article information

Conflict of interest: None declared.

Open access: This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license, allowing to download articles and share them with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially. For commercial use, please contact the journal office at kardiologiapolska@ptkardio.pl.

How to cite: Katarzyńska-Szymańska A, Grymuza M, Chmielewska-Michalak L, et al. Implementation of laser equipment in a center experienced in lead extraction: safety and efficacy within 1-year follow-up. Kardiol Pol. 2021; 79(5): 569–571, doi: 10.33963/KP.15983.

REFERENCES