Study population
This post-hoc analysis used clinical data of 3344 patients who underwent transvenous lead extraction between March, 2006 and September, 2020. All information relating to patients and procedures was entered into the computer on an ongoing basis. For the purposes of comparison the cohort was divided into two groups: group A consisting of 126 adult patients who were 19–29 years old, mean age 23.6 ± 3.1, at their first CIED implantation (mean age at extraction 37.9 ± 9.2) and group B comprised of 2659 adults who were > 40 years of age, mean age 58.4 ± 11.5, at the time of their CIED implantation and < 80 years of age, mean age 66.5 ± 9.4, at the time of transvenous lead extraction. No other patient exclusion criteria were used. Some patients with very old leads or abnormal lead route (strained, looped) were referred for elective system replacement at our tertiary reference care center.
This study analyzed demographic, clinical, CIED-related and procedure-related (including success and complications) data. The SAFeTY TLE score was used to predict the risk of major complications14, with an online calculator available at http://alamay2.linuxpl.info/kalkulator/.
Lead extraction procedure
Lead extraction procedures were performed using mechanical systems such as polypropylene Byrd dilator sheaths (Cook® Medical, Leechburg, PA, USA), mainly via the implant vein. If technical difficulties arose, alternative venous approaches and/or additional tools such as Evolution (Cook® Medical, USA), TightRail (Spectranetix, USA) sheaths, lassos, basket catheters were utilized. Laser cutting sheaths were not used. In both groups lead extraction was performed by a team consisting of the same experienced operator, a second operator having experience with pacing therapy and a cardiac surgeon, whereas an anesthesiologist and echocardiographer were often but not always present during the procedure.
Definitions
Indications for TLE and type of periprocedural complications were defined according to the 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction12.
Extraction procedures of lead(s) older than one year were defined according to the guidelines on management of lead-related complications (HRS 2009 and 2017, and EHRA 201811,12,13.
Procedural success was defined as removal of all targeted leads and all lead material from the vascular space, without any permanently disabling complication or procedure-related death11,12,13.
Clinical success was defined as removal of all targeted leads or retention of a small (< 4 cm) portion of the lead that did not negatively impact the outcome goals of the procedure or permanently disabled the patient (only in patients with noninfectious indications for TLE)11,12,13.
Partial radiographic success was defined as leaving a lead tip or a fragment of lead less than 4 cm11,12,13.
Statistical analysis
The Shapiro–Wilk test showed that most continuous variables were normally distributed. For uniformity, all continuous variables are presented as the mean ± standard deviation. The categorical variables are presented as numbers and percentages. The significance of differences between groups was determined using the nonparametric Chi2 test with Yates correction or because of the large disproportion in the size of the compared groups with the Mann–Whitney U test, as appropriate.
To determine which parameters have impact on the major complications (MC) occurrence and clinical and procedural success the following variables were included in the regression analysis of risk factors of major complication and prognostic factors of clinical and procedural success: patient’s age during the first CIED implantation, patients age during TLE, gender, value of left ventricle ejection fraction, cteatinine level, body mass index, Charlson’s comorbidity index, indications for TLE (infectious vs non-infectious), kind of CIED system (conventional, or with HV lead), presence/extraction of abandoned leads, number of leads in the heart (number of leads in the system + number of abandoned leads), number of CIED—related procedures before TLE and dwell time of the oldest extracted lead.
The variables with p < 0.1 in the one-variable regression analysis are presented in Table 5 and were included in the multivariate analysis. Due to the small number of major complications (n = 9), in group A, a two-variable analysis was performed comparing the dwell time of the oldest extracted leads with other variables, which achieved statistical significance (p < 0.1) under univariable analysis.
In order to assess the significance of the influence of the patient’s young age during first implantation, and the dwell lead time a binary regression analysis was performed too. To analysis age of patients between 19 and 29 years during first CIED implantation and the dwell lead time above 10 years were included. Impact of above variables on the major complications occurrence, achieving of clinical and total procedural success, presence of connective tissue on the leads and connective tissue adhesions of leads to heart structures were tested.
Statistical analysis was performed with Statistica version 13.3 (TIBCO Software Inc.).
Approval of the Bioethics Committee
All patients gave their informed written consent to undergo TLE. The use of anonymous data from patient’s medical records was approved by the Bioethics Committee at the Regional Chamber of Physicians in Lublin, Poland no. 288/2018/KB/VII.
All methods were performed in accordance with the relevant guidelines and regulations.
