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Use of the new rotating dilator sheath TightRail™ for lead extraction: A bicentric experience

Abstract Aim The aim of this study is to assess the safety and efficacy of the new bidirectional rotational mechanical sheath TightRail™ (Spectranetics) for lead extraction. Methods and results This is a bicentric prospective study that included patients who underwent a transvenous lead extraction (TLE) in two Italian centers (San Raffaele Hospital and Humanitas Gavazzeni Hospital). From November 2016 to December 2018, 26 patients underwent a TLE procedure in which the TightRail™ was used. The new TightRail Sub‐C was used in 20 (76%) patients to overcome the fibrosis between the vessel and the first rib. Median age was 69 (IQR 60.7‐79.5) years. The indication for TLE were infection (57.7%) or lead dysfunction (42.3%). A total of 57 leads (range 1‐4), 40 of which using the TightRail (range 1‐4), were extracted. Overall mean implant duration was 98.2.0 ± 66.5 months. Mean age of the lead extracted with the TightRail sheath was 99.1 ± 70.2 months and was higher compared to that of the leads extracted manually (84.4 ± 60.3 months, P = .001). The overall clinical success was 100% and complete procedural success without the use of a snare was achieved in 98.3%. There were no cases of death or major complications and only two minor complications occurred. All patients were event‐free at 6‐month follow‐up. Conclusion This initial experience using the TightRail™ suggests a high safety and efficacy profile for extractions in a wide range of lead age.

life-threatening complications. 3 However, the removal of chronically implanted leads, which develop fibrous adhesions with surrounding vessel walls and tissues, could be challenging. To address this issue many extraction techniques have been developed including laser sheaths, mechanical sheaths, or electrosurgical dissection sheaths. [4][5][6][7] A bidirectional rotational mechanical sheath (Evolution RL, Cook medical) has proved to be extremely safe and effective with long implanted leads. 8,9 However, powered sheaths have been related to higher complication rates, 2 and concerns can be raised about their use in case of recently implanted leads. The treated metal distal tip of Evolution RL allows the system to pass through adhesions but could also damage surrounding tissue. A new bidirectional rotational mechanical sheath TightRail (Spectranetics), with a more flexible shaft that provides high co-axiality with the lead and a dilating blade that remains shielded until activated, is now available. Multicentric data about its safety and efficacy still lacks. The aim of this study was to report our preliminary experience with the TightRail (Spectranetics) sheath for lead extractions at two tertiary care Italian centers.

| Patients
This is a prospective study that included all patients who underwent a TLE in which the TightRail was used, either alone or in association with other extraction sheath, at two tertiary referral centers: San Raffaele Hospital (Milan, Italy) and Humanitas Gavazzeni Hospital (Brescia, Italy). Indication for TLE included infection and lead malfunction. For each lead, the underlying type (active/passive fixation, single double coil catheters), duration of implant, and fixation modality were recorded. All patients provided a written informed consent before the procedure and the study was approved by the Institutional Committee of Human Research at our Hospital.

| Extraction procedure
All TLE procedures were conducted in the electrophysiology laboratory by two skilled operators (PM and GM), with an experience of more than one thousand of extracted catheters each and ability to perform TLE with a wide range of tools, including laser and rotational sheaths, and performed under general anesthesia or sedation and ECG, pulse oximetry, and arterial blood pressure monitoring, with a cardiothoracic surgeon on standby. 10 A subclavian approach was initially preferred; if the patient was pacemaker (PM) dependent, a temporary right ventricular active fixation lead was placed from the femoral vein. All patients underwent TLE with a standard stepwise approach, as previously described. 11 At first, the leads were dissected free from the scar in the pocket, then simple manual traction or traction on a locking stylet (Liberator Universal locking stylet, Cook Vascular Inc and/or LLD ® Lead Locking Device; Spectranetics), was attempted, avoiding disrupting the lead integrity. If unsuccessful, the new TightRail™ (Spectranetics) dilator sheath was used. In cases of excessive fibrous adhesions or calcification between the vessel and first rib the TightRail Sub-C (Spectranetics), a shorter mechanical dilator, was used at the discretion of the physician. The A shorter, stiffer, and more aggressive version of the TightRail, the so-called Sub-C, is available to overcome heavy calcifications under the clavicle, which are not uncommon.

| Outcomes
All patients were monitored for procedure-related complications in the operating room and during hospital stay. Clinical outcomes and adverse events were prospectively monitored at 30 days and 6 months by ambulatory direct visit or phone interview.

| RE SULTS
The TightRail™ (Spectranetics) was first used at San Raffaele  Tables 1 and 2, respectively. second procedure during the same hospitalization; after collegial discussion, reimplantation was not performed in four patients. All the leads were extracted using initially the subclavian approach.
Twenty patients (76%), because of adherence between the vessel and the first rib, were initially approached with the TightRail Sub-C.
The overall clinical success was 100%. Complete procedural success without the use of a snare was achieved in 98.3%. In one case (patient #11), the Evolution RL was needed to complete the extraction of a right ventricular pacing lead after a first ineffective attempt with the TightRail, while in other two (#3, #8) the Evolution RL was used to complete the extraction under operator's choice. There were no cases of death or major complications and only two minor complications occurred: small pneumothorax treated conservatively in patient #3 and a hematoma of the device pocket in patient #8 who was on anticoagulant therapy for atrial fibrillation. No patient required admission to the internal care unit after the procedure.
Complete follow-up was available for all patients. The 30-day and 6-month survival rate were 100%. Patient #1 underwent successful aortic valve substitution 1 month after TLE. All patients were event-free at 6-month follow-up.

| D ISCUSS I ON
To the best of our knowledge, this is the first prospective multi-  14 ; compared to this report, in our multicentric experience the mean lead age was higher; Sawhney described successful TLE with TightRail™ in 3 patients. 15 Compared to these previous reports, in our multicentric experience the median lead age was higher, further confirming the possibility to use the TightRail™ also in long-standing, chronically implanted leads.
Moreover, we are the first to describe the use of TightRail Sub-C to exceed the excessive fibrous adhesions or calcification between the vessel and first rib that was previously considered a critical issue about the use of TightRail for lead extraction.
Amount of evidence is available about the new Evolution RL mechanical sheath that has proven to be safe and effective for long-standing lead extraction in single and multicentric registries. 8,16 The use of powered sheaths has been shown to be associated with higher procedure related major complications. 2

| Limitations
The main limitations are represented by the small size of the population studied and by the lack of comparison with other mechanical dilator sheaths. Larger scale randomized studies should be conducted in the future to identify appropriate decision-making and therapeutic strategies to deal with the increasing request of TLE procedures.

| CON CLUS IONS
This initial experience using the TightRail suggests a high safety and efficacy profile for lead extraction when initial fibrous adherence is present.

ACK N OWLED G M ENTS
We thank Terenzia Natale for helping in data collection.

CO N FLI C T O F I NTE R E S T
The authors declare no conflict of interests for this article.

I N FO R M E D CO N S E NT
All patients provided informed consent for data collection and the study was in accordance with the ethical standards of the institutional research committee.