Abstract
Background. Transvenous lead extraction (TLE) is recommended in cases of local and systemic infections related to cardiac implantable electronic devices (CIEDs). Additionally, TLE is indicated in the event of lead damage or CIED malfunction. The extraction procedure is associated with a risk of life-threatening complications.
Objectives. The aim of the EVO registry was to assess the safety and efficacy of birotational Evolution tool usage.
Materials and methods. This registry study was prospectively conducted in 8 high-volume implantation centers in Poland. The study included 133 patients aged 63.5 ±15.1 years, and 76.69% were male. Indications for the procedure were: local or systemic infection (33.1%) and lead dysfunction (66.9%). The number of leads extracted varied from 1 (39.84%) to 3 (9.77%).
Results. Clinical procedural success was achieved in 99.1% of cases. A total of 226 leads were extracted, and 206 used the Evolution system. Two procedural strategies were identified while using the Evolution system: (1) usage of locking stylet, propylene sheaths and the Evolution system (118 leads, 52%) – group A; (2) usage of locking stylet and Evolution (88 leads, 39%) – group B. There were no differences in the number of complications between these 2 groups. The extraction time was significantly shorter (p = 0.02) in group B than in group A. Major complications occurred in 5.2% of cases with 2 intraprocedural deaths. Minor complications occurred in 1.5% of patients.
Conclusions. The registry confirmed the efficacy and relative safety of the birotational Evolution sheath. Using the rotational sheath as a first attempt significantly reduces extraction time without compromising its safety.
Key words: transvenous lead extraction, rotational sheaths, pacing leads, defibrillation leads, CIED complications
Background
Treatment of complications related to cardiac implantable electronic devices (CIEDs) remains challenging for the medical personnel involved in this method of therapy. Complete device and lead extraction is recommended in cases of local and systemic infections related to previously implanted systems.1, 2, 3 Moreover, lead extraction is indicated in cases of lead damage or malfunction. Progression of the underlying heart disease requires upgrading the previously implanted system in a growing number of patients. In many cases, it is necessary to extract the lead in order to regain vascular access for the placement of new leads. Thus, the number of indications for transvenous lead extraction (TLE) is steadily growing. Despite technological progress and the release of new, advanced tools dedicated to TLE, the procedure is still associated with the risk of life-threatening complications, particularly cardiac tamponade or superior vena cava injury.4, 5 Superior vena cava injury occurred more frequently with the use of laser or powered sheaths, which seemed to discourage some physicians from their broad use despite higher effectiveness.5 In some countries, reimbursement concerns may also influence the choice of the TLE method.6 The bidirectional, rotational Evolution mechanical sheath (Cook Medical, Bloomington, USA) is a relatively new extraction tool. Its efficacy and safety have been shown in several retrospective studies and 1 multicenter prospective study.7, 8, 9, 10, 11 However, the data are still limited, and several controversies concerning Evolution tool utilization and an optimal TLE strategy remain unresolved. One issue concerns the use of Evolution tool either as a first choice during the TLE procedure or when the initial attempt with nonpowered sheaths has failed in terms of efficacy and safety, with potential disadvantages related to the cutting properties of the Evolution tool.
Objectives
The aim of this prospective multicenter registry (EVO registry) study was to assess the safety and efficacy of the rotational Evolution tool usage, and evaluate the 2 different strategies of TLE procedures.
Materials and methods
This registry study was prospectively conducted in 8 high-volume centers (>30 TLE procedures per year) in Poland, in the years 2019–2021. The patients (≥18 years old) were included in the study if at least 1 lead was extracted using the Evolution system. The Evolution system was applied at the discretion of the operating physician. The use of additional tools and techniques was based on the decision of the operating team. The procedures were performed according to the current European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) guidelines.2, 3 All patients signed informed consent for lead extraction and emergency cardiosurgical procedure, if needed. Data were recorded during the procedure and placed in the case report forms immediately after the procedure, and thereafter were supplemented with clinical and demographic preoperative data. Postoperative and follow-up data were obtained prospectively. The study was approved by the ethics committee of the National Institute of Cardiology, Warsaw, Poland (approval No. IK-NPIA-0021-103/1755/18 issued on November 17, 2018).
Lead extraction procedure
As mentioned above, all procedures were performed according to the EHRA and HRS recommendations.2, 3 An arterial line for continuous blood pressure monitoring was placed in all cases. A cardiosurgical team and an extracorporeal circulation machine were on standby in the operating room. A temporary pacing wire was introduced by either the femoral or jugular vein contralateral to the CIED insertion site in pacemaker-dependent patients. The superior approach was used as a first choice in all cases. After the skin incision, the leads were dissected free and the fixation sutures were removed. The order of extracted leads was decided by the operating physicians. First, an attempt to place the standard wire into the lead lumen was made in order to check its patency and unscrew the fixation mechanism in active fixation leads (if possible). Second, gentle manual traction was performed. If this approach was unsuccessful, the Liberator Locking Stylet (Cook Medical) was inserted into the lead lumen under fluoroscopic control and its locking mechanism was activated. In the cases of severe extravascular calcifications and adhesions in the subclavicular region, either steel sheaths or Evolution Shortie tools (Cook Medical) were applied. To grasp lead insulation and obtain greater lead stability, silk sutures were used. A Bulldog™ Lead Extender (Cook Medical) tool was used for the removal of lumenless cardiac leads. Then, leads were extracted using either polypropylene Byrd dilator sheaths (Cook Medical) or the bidirectional Evolution mechanical system. The use of the nonmechanical or mechanical tool as the first approach depended on the decision of the operating team. In cases of unsuccessful superior approach or in order to remove remnant fragments, the femoral approach with dedicated tools such as the Needle’s Eye Snare® (Cook Medical) was used. In patients with noninfective indications for lead extraction, a new device was implanted during the same session, while it was postponed in patients with CIED-related infections, in accordance with the EHRA recommendations. In all the cases, the indications for reimplantation were reassessed.3 Alternative approaches, i.e., leadless pacemakers or subcutaneous implantable cardioverter-defibrillators (ICDs), were applied if clinically justified.
Definitions
Clinical and procedural success, as well as complications, were determined according to the 2017 HRS Expert Consensus.
Complete procedural success was defined as the removal of all targeted leads and all lead materials from the vascular space without the occurrence of any permanently disabling complication or procedure-related death.
Clinical success was defined as the removal of all targeted leads and lead materials from the vascular space or retention of a small portion of the lead (≤4 cm) in the absence of complications.
Major complications were defined as outcomes that were life-threatening and/or resulted in significant or permanent disability or death, or required surgical intervention.
Minor complications were defined as events related to the procedure that required medical intervention or minor procedural intervention.
Procedure time was defined as the time from the first skin incision to the final wound closure.
Extraction time was defined as the time from lead release from pocket adhesion to complete or incomplete lead extraction.
Statistical analyses
Statistical analyses were conducted using Statistica Tibco v. 13.3 software (StatSoft Inc., Tulsa, USA). Categorical variables were presented as numbers (percentages), and differences between patient groups were compared using the χ2 test. The Shapiro–Wilk test evaluated the normality of data distribution. The continuous variables were provided as medians with interquartile range (IQR) or mean with 95% confidence interval (95% CI), and compared using the Mann–Whitney U test, Kruskal–Wallis test or unpaired Student’s t-test, where appropriate. A one-way analysis of covariance (ANCOVA) was performed to adjust for potential confounders. A Pearson’s or Spearman’s correlation coefficient was used to analyze the associations between continuous variables. To calculate the odds ratio (OR) with a 95% CI, the cutoff point was calculated based on receiver operating characteristic (ROC) curves. Results were considered statistically significant when the value of p < 0.05.
Results
The study group consisted of 133 patients who met the inclusion criteria, i.e., patients who had at least 1 lead extracted using the Evolution device. The mean age was 63.5 ±15.1 years and 102 patients were males (76.7%). The mean body mass index (BMI) was 27.3 ±5.9. Twenty-six patients (19.5%) underwent previous cardiosurgical procedures, including 2 patients operated on for congenital heart diseases and 1 with an implanted left ventricular assist device. Characteristics of the patients are presented in Table 1. The number of leads in the vascular system ranged from 1 to 4. The mean indwell time was 133.3 ±87.1 months (ranging from 1 month to 399 months) (Table 2). The most common CIED was a single-chamber ICD (48 patients, 36%). Three patients had either pacing or abandoned defibrillation leads after a previous system upgrade. Two patients were implanted with subcutaneous leads, including 1 implanted with a subcutaneous ICD, while the other had an additional defibrillation coil connected to a transvenous ICD.
Lead extraction indications
Local or systemic infection was an indication for TLE in 44 patients (33.1%). Transvenous lead extraction was performed due to noninfectious indications, mainly lead dysfunction, in the remaining 89 patients (66.9%). In this group, regaining venous access for new lead implantation or system upgrade was an additional indication in 35 cases (26.3%).
Procedural data
In total, 226 leads were extracted, of which 206 were removed using the Evolution system. The remaining 20 leads were removed with manual traction only (n = 5) or with Liberator Locking Stylet and polypropylene Byrd dilator sheaths (n = 15) (Figure 1). For all leads removed with manual traction, the indwell time was shorter than 6 months. Lead characteristics are presented in Table 2. The femoral approach with the Needle Eye Snare® was applied in 2 cases of incomplete extraction with the superior approach for the removal of remnant parts. Steel sheaths for the dissection of extravascular adhesions in the subclavicular region were used in 64 cases (28.3%).
The number of leads extracted during a single procedure varied from 1 (53 cases, 39.84%) to 3 (13 procedures, 9.77%) (Table 2). Among the 80 procedures where more than 1 lead was removed, the right ventricular lead was extracted first in 59 cases (73.75%), whereas the right atrial was extracted first in the remaining 21 (26.25%) cases.
Complete procedural and clinical success rate
Clinical success was achieved for 224 leads (99.1%), with 214 leads completely removed (complete procedural success = 94.7%). Eight leads were partially removed with retention of a small portion of the lead (<4 cm), which did not negatively impact the outcome goals of the procedure. One lead was not removed and the remaining lead was removed during a rescue cardiosurgical procedure (Figure 2).
Complications
Major complications occurred in 7 patients (5.2%). There were 2 intraprocedural deaths during the procedure. A 71-year-old male with severely impaired left ventricular function (left ventricular ejection fraction (LVEF), 12%) died during the electromechanical dissociation after a partial defibrillation lead extraction (<4 cm residual left). The patient was implanted with an ICD 36 months before the index procedure. Transvenous lead extraction was performed due to a system infection. The 2nd patient with complications was a 71-year-old male with post-myocardial heart failure (ejection fraction (EF), 20%) and a history of coronary artery bypass surgery. He was referred for TLE due to the dysfunction of the defibrillation lead implanted 9 years before the index procedure. During the procedure, cardiac tamponade occurred and the patient died despite immediate pericardiocentesis and cardiosurgical intervention.
The remaining complications included cardiac tamponade requiring emergency cardiosurgical repair (1 case), pericardiocentesis (1 case), bleeding from the subclavian vein requiring immediate surgical repair (1 case), asystole (1 case), and ventricular fibrillation (1 case). Minor complications (2 patients, 1.5%) included pneumothorax (1 patient) and worsening tricuspid valve insufficiency (1 patient). Pneumothorax occurred in patients who required subclavian vein puncture for new lead implantation. Thus, the complication might be related to this procedure and not necessarily to TLE. Detailed information on patients with complications is presented in Table 3.
Two patients died after the procedure during index hospitalization – 1 due to septic shock and 1 due to cardiogenic shock.
TLE strategies
Among leads extracted with the use of the Evolution system, 2 procedural strategies were identified (Figure 1):
1) use of locking stylet, propylene sheaths and Evolution (118 leads, 52%) – group A;
2) use of locking stylet and Evolution (88 leads, 39%) – group B.
Comparison of groups A and B
The use of the Evolution sheath as a first choice was more frequent in the case of right atrial leads (OR – 1.54), pacing leads (OR – 1.54) and leads with dwell time ≤160 months (OR – 1.63) (Figure 3).
The extraction time was significantly shorter (p = 0.02) in group B than in group A (Table 4).
There were no differences in the number of complications between those 2 groups, although the overall small number of complications did not allow us to reach valid conclusions. There was 1 procedure-related death in group A and 1 in group B. However, the death in group B was not caused by mechanical complications related to the TLE procedure but was rather related to the patient’s underlying heart disease. Other major complications occurred in 2 patients in group A and 1 patient in group B.
Discussion
The design of our study aimed to investigate the everyday practice related to TLE and the use of the birotational Evolution mechanical sheath. Due to the complexity of the TLE procedure and heterogeneity of both patients and clinical scenarios, our knowledge on the efficacy of TLE is based mainly on retrospective and observational studies with the exception of the prospectively conducted Transvenous Lead Removal Using the Cook Evolution LEAd Extraction SystEm (RELEASE) trial.4, 7, 8, 9, 10, 11 Thus, our prospective multicenter registry seems to add valuable data to the current knowledge regarding the safety and efficacy of lead extraction. The data were obtained prospectively from 8 high-volume centers (defined as >30 TLE procedures per year). The studied population did not differ from other studies investigating lead extraction, although it should be noted that in terms of indications and predominance of noninfectious indications, our registry was more similar to the RELEASE study population than to older studies, thereby reflecting the current trend in clinical practice. The leads’ mean dwell time was longer in our study than in the RELEASE or European Lead Extraction ConTRolled (ELECTRA) studies. In our study, the mean dwell time was 11.56 years, whereas, in the RELEASE and ELECTRA studies, the dwell time was 7.4 and 5.3 years, respectively. Taking into account the longer dwell time, the efficacy of the TLE procedures was very high, with a complete success rate of 99.1% and a clinical success rate of 94.7% for all extracted leads, and 99.1% and 94.1% for leads extracted with the Evolution sheaths. The results are similar to those reported in the RELEASE study and current observational studies with birotational Evolution sheaths.4, 7, 8, 9, 10, 11
The number of major complications was similar to those reported in the ELECTRA registry, and the intraprocedural complication rate was slightly higher than in the RELEASE trial (3.8% compared to 2.6%).11, 12 However, it should be noted that 1 major complication and periprocedural death was mainly related to the patient’s underlying cardiological status and was not caused by the mechanical complications of the elaborated procedure. The 2nd death occurred as a result of cardiac rupture despite immediate cardiosurgical intervention. The ELECTRA registry reported 20% mortality among patients with cardiac avulsion or tear despite immediate pericardiocentesis and/or cardiosurgical repair.12 Moreover, it should be noted that according to Manufacturer and User Facility Device Experience (MAUDE) analysis, the number of lethal complications associated with rotational sheaths may be underestimated and underreported.5
In our cohort of patients, there were no superior vena cave injuries, which are considered the most life-threatening TLE complication.
Among minor complications, pneumothorax was probably a complication of subclavian vein puncture for the new lead placement and not the TLE procedure itself. It is possible to reduce the risk of this complication by avoiding the attempt of subclavian vein puncture and regaining vascular access by sheaths used for lead removal.13 Similarly, ventricular fibrillation and asystole may occur during each intervention within cardiac cavities; thus, these complications are not specific to lead extraction only. However, it should be stressed that every possible effort should be made to maintain efficient pacing during the whole TLE procedure.
In contrast to the RELEASE study and the observational studies, in our study, the decision to use a mechanical sheath was made during the procedure, whereas in the RELEASE study, patients were found eligible for the study if the investigated device was intended to be used during the procedure, although only patients who had at least 1 lead removed with the Evolution system were enrolled.11 Also, contrary to the aforementioned study, the use of nonmechanical sheaths as the first attempt was allowed, which seems to better reflect everyday clinical practice in our country as well as in other European countries. According to the data from the ELECTRA registry, nonpowered mechanical sheaths were used for lead extraction in 36.34% of cases.4, 12 In Poland, mainly due to reimbursement issues,6 mechanical sheaths are used even more frequently.14, 15 Greater experience with mechanical sheaths and the fear of vascular complications reported when using more advanced tools might play a significant role in the selection of procedural strategy.5, 13 Thus, our study, which showed a high efficacy and a low number of complications with rotational mechanical sheaths, seems to play an important role in the ongoing discussion concerning an optimal TLE strategy. Of note, in 52% of cases in our study, the Evolution sheath was introduced when the initial attempt with Byrd dilator sheaths was unsuccessful. In all but 2 cases, this approach allowed us to achieve complete or clinical success without compromising the safety of the procedure. In comparison to this approach, the use of Evolution as a first choice strategy shortened the extraction time and thereby could lower the rate of late complications. Due to the registry design, we could not provide any evidence for the hypothesis. However, the relationship between procedure duration and infection rate shown in many studies and meta-analyses was recognized in EHRA guidelines for CIED infections as one of the most important risk factors.16, 17 Importantly, any effort aimed at shortening the procedural time is important due to the limited availability of hybrid operation rooms and cardiosurgical and anesthesia personnel.
Based on our study, it is difficult to point out the factors that influenced the operators’ choice, that is to say, the use of Evolution sheath as a 1st or 2nd attempt. The fact that Evolution was used as a first choice, more frequently in the case of atrial and pacing leads, could be explained by the operation strategy, i.e., by choosing to extract the right ventricle lead before other leads in 75% of cases. If the Evolution tool was used for right ventricle lead extraction, it was also used for the extraction of the remaining, primarily right atrial, leads. The same reasoning explains the utilization of Evolution as the first choice for pacing leads removal. It remains unclear why Evolution was more willingly used for the extraction of leads with relatively shorter dwelling time (Figure 3). It should not be ruled out that other factors like pocket adhesions might influence the operating physician’s decision on TLE strategy, although this is only speculation because such data were not collected in the registry.18
Limitations
The registry is an observational, nonrandomized study with all its imperfections, especially the lack of a reference group. As discussed above, such a trial design would be very challenging within the context of lead extraction procedures. The patients were included in the registry based on the intraprocedural decision to introduce the Evolution tool either as a first or subsequent approach, and no data concerning patients treated with other methods in the same hospitals over the same time period were collected. Moreover, the study involved only 8 hospitals in 1 country and may not be representative of other populations.
The procedural time was not analyzed on purpose because it depends on reimplantation time in the case of noninfective complications. Thus, reimplantation time may be prolonged mainly due to the obstacles related to new lead placement, which has been reported, especially in the context of new left ventricular lead introduction.19, 20
Conclusions
The results of the prospective, multicenter registry confirmed the efficacy and relative safety of the birotational Evolution sheath used for TLE. The strategy of using the rotational sheath as a first attempt significantly reduces extraction time without compromising safety.
