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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 24
| Issue : 2 | Page : 159-163 |
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Outcome of percutaneous cardiac lead extraction in chronically implanted leads with tight rail rotating lead locking device
Prabhat Sharma1, Naveen Agarwal2, Balwinder Singh3
1 Department of Cardiology, Base Hospital, New Delhi, India
2 Department of Cardiology, Max Super Speciality Hospital, Mohali, Punjab, India
3 Department of Cardiology, CH (CC), Lucknow, Uttar Pradesh, India
| Date of Submission | 01-Mar-2022 |
| Date of Decision | 07-Mar-2022 |
| Date of Acceptance | 10-Mar-2022 |
| Date of Web Publication | 10-Aug-2022 |
Correspondence Address:
Prof. (Lt Col) Prabhat Sharma
Asst Prof, Cl Spl Med and Cardiology, Dept of Cardiology, Base Hospital, Delhi Cantt - 110010, New Delhi
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/jmms.jmms_33_22
Aims: Despite advances in lead extraction tools, percutaneous lead extraction is a complex procedure associated with morbidity and mortality. No standards or directives exist to guide the choice of extraction tool or approach, and all operators tend to have their preferred method. The data on removing chronically implanted cardiac leads are scarce in India; reporting outcomes with emerging extraction technology is therefore encouraged. This is the first data submitted for the chronic difficult to explant cardiac leads from India. Materials and Methods: Thirteen lead extraction procedures using the Spectranetics tight rail rotating dilator sheath at the tertiary care center over two years are described here. Results: All patients had chronically implanted leads (mean duration 10.4 years), and the pre-procedure venogram showed occluded left subclavian and brachiocephalic veins with extensive collateralization. All leads were extracted successfully using the rotating dilator sheath, and this kit also retained vascular access by venous recanalization. There were no other procedure-related complications, and all patients remained well with suitable lead parameters at 1-year follow-up. Conclusions: The tight rail rotating extraction tool is safe and effective in chronically implanted leads. Moreover, it helps preserve vascular access by recanalizing long tortuous occlusions. Its use across various centers and a larger number of patients will be required to confirm our results.
Keywords: Cardiac implantable electronic devices, epidemiology, lead extraction, lead locking device, pacemaker
How to cite this article:
Sharma P, Agarwal N, Singh B. Outcome of percutaneous cardiac lead extraction in chronically implanted leads with tight rail rotating lead locking device. J Mar Med Soc 2022;24:159-63 |
| Introduction | |  |
Advances in the management of cardiac arrhythmias and failure have resulted in the increasing use of pacemakers, implantable cardiac defibrillators, and cardiac resynchronization. There is a trend for an increasing number of cardiac implantable electronic devices (CIEDs) being offered to patients, as medical services improve in India.[1]
With increasing CIED implantation, there are increasing clinical scenario which necessitates lead extraction/removal.[2] The most important need for lead extraction is CIED infection followed by device or lead dysfunction, a necessity for up-gradation of device or lead recalls.[3] To date, data regarding lead extraction and extraction devices are sparse in India.
Lead Extraction is the term referred to the removal of pacemaker leads implanted more than 1 year, requiring tools other than standard stylets and through the route other than the vein of implantation.[3]
Lead explantation is the removal of lead implanted <1 year, through the vein of implantation and with the standard tools.[3]
Partial extraction is the term used when some portion of lead <2 cm is left behind.[3]
Lead removal is the removal of lead by any technique.
| Materials and Methods | | |
This is a retrospective observational study from a single armed forces tertiary care center. A total of 13 lead extraction procedure were done at our center from June 2017 to June 2019 with novel LLD® Lead Locking Device, Spectranetic Corp, Colorado Springs, US. [Figure 1]. | Figure 1: Spectranetics® tight rail Lead locking device with extracted right ventricle (RV) lead
Click here to view |
Tight rail lead locking device
All lead extractions in this series were performed using the endovascular spectranetics tightrail rotating dilator sheath extraction kit. This system is a “hand powered” mechanical sheath, which consists of a flexible inner shaft, static outer shaft, shielded cutting dilation blade with a bidirectional rotational mechanism, and a trigger activation handle.
The flexible inner shaft enables the operator to remain coaxial to the lead while maintaining stable forward progression through tortuous vasculature and fibrotic/calcified lesions. The inner sheath is fixed to a trigger activation handle that rotates the sheath and activates the blade. The dilating blade remains shielded inside (until activated by the operator) and hence allowing safe counter-traction at the lead's distal tip. The blade has a bidirectional mechanism, which rotates 540° with each full trigger activation (270° clockwise and 270° counter-clockwise) while extending the blade just half a centimeter to allow dilatation of fibrosed and calcified lesions. The outer shaft is optional and does not rotate with the blade. This can be used based on the clinical scenario and operator preference.
Preprocedure evaluation
As per institutional protocol, patients were evaluated by a heart team approach consisting of a cardiologist, cardiac anesthetist, cardiovascular surgeon, and vascular surgeon. Patient and relatives were counseled and peri-procedure risk and benefit were well explained. All the patients underwent baseline investigation as per preprocedure protocol including hemogram, blood grouping and cross matching, biochemistry, prothrombin time and international normalized ratio, echocardiography, and chest X-ray. Antiplatelets were stopped before the procedure. Two pints of cross-matched blood were demanded and kept ready during each procedure. Cardiothoracic and vascular surgical team (CTVS) team was informed and one dedicated OT was kept ready as backup during each procedure at the catheterization laboratory.
Lead extraction procedure
The lead extraction procedures were carried out in the cardiac catheterization laboratory either under a general anesthetic or under conscious sedation and local anesthesia (LA) with invasive blood pressure and oxygen saturation monitoring.
Preferentially procedures were done under LA, except two cases which were done under general anesthesia (GA) (one patient was desaturating on the table and the other was a specially abled male who was planned for elective GA). Temporary transvenous pacing was established in dependent patients. For all cases, intravenous antibiotics were administered before the procedure and an aseptic environment was maintained. After skin disinfection, the generator pocket was exposed and the leads were disconnected from the CIED generator and then separated from the fibrosed capsule using blunt dissection and cutting diathermy. All leads were extracted using a superior approach via the implant vein by the tight rail extraction.
Postintervention all patients were hospitalized at least for 3 days and were managed with supportive treatment including broad-spectrum antimicrobials and blood transfusions if required. As per institutional policy, all patients received CIED at least 48 h postprocedure.
| Results | | |
In our study, the mean age of the patient was 60.2 years. Among a total of 13 lead explanations, 10 were males and 3 were females. The mean duration of lead was 10.4-year-old. Baseline characteristics and underlying comorbid conditions are as stated in [Table 1]. Three patients developed major bleeding requiring blood transfusions. No other major complications were observed. | Table 1: Characteristics of 13 patients undergoing lead extraction by LLD®, Spectranetics Corp, US
Click here to view |
Of a total of 13 procedures, 11 were successful, the success rate being 84.6%. Two patients had partial lead explantation of defibrillator lead and the loose end of leads were capped and secured – both were dual shocking defibrillator leads, and apart from being thicker than pacemaker lead it had difficult explantation due to pronounced fibrosis and long venous occlusion with extensive tortuous collaterals on venogram.
The most common reason for lead explantation was pocket site infection [(61.5% cases); [Figure 2]]. One patient underwent lead explantation because of the inability to procure DF1 compatible PGR; in the government setup. One patient had partial explantation of RA lead during the procedure; being broken midway and the distal lead was retrieved by snaring through the femoral route. One patient received a leadless pacemaker MICRA™ Transcatheter Pacemaker System, Medtronic (MICRA) on day 5 postprocedure. | Figure 2: Chronically explanted leads and generator due to pocket site infection
Click here to view |
All the patients were monthly followed up for the first 6 months followed by 3 monthly follow-up. Two patients were lost to follow-up after the 1st month of follow-up, rest 11 patients were doing well till the 1st year of the lead extraction procedure.
| Discussion | | |
With the increase in CIED clinical applications for bradycardia, tachyarrhythmia, and heart failure, CIED infection has become increasingly prevalent in cardiac disease management.[4],[5]
National Inpatient Sample (NIS), United States, Greenspon et al. reported that during the study period between 1993 and 2008, the incidence of CIED infection was 1.61%. The probability of CIED infections was higher among patients with ICDs than among those with pacemakers.[6]
The increase in the number of CIED implants in the past decade has been paralleled by an increase in device extraction. Lead extractions are performed in various centers using a variety of extraction tools with a marked reported difference in clinical success.[7] In this rapidly evolving field, new extraction tools and techniques are being introduced and require reporting of clinical outcomes to help build a standardized approach to lead extraction.
Extractions can be completed using a variety of approaches and tools, including simple manual traction, locking stylets, telescoping sheaths, femoral snares, mechanical cutters, and laser sheaths. Despite these several available extraction tools, no standardized approach or recommendations for the choice of extraction tool or technique exist. With a combination of extraction tools, the success rates of lead extraction can be increased to 90%.[8] However, along with immediate procedural success, clinical safety has to be considered and newly emerging tools and techniques should focus on the extraction of long implanted leads.
We are reporting the efficacy of a novel mechanical dilator sheath in percutaneous endovascular lead extraction and recanalization of long occlusions for the preservation of vascular access. The bidirectional cutting mechanism of the tight rail effectively dilates calcified and fibrotic lesions with the dilating blade being safely shielded until activated. The system is flexible enough to remain coaxial to the lead and enable steady forward progression through tortuous vasculature safely. Furthermore, little or no traction is required on the locking style since the tight rail sheath is very flexible. This allows it to follow the body of the lead around bends such as the left brachiocephalic-SVC junction and through tortuosities minimizing the risk of traction-induced conductor coil fracture. Significant traction to the locking stylet is only necessary once the tip of the tight rail sheath is in contact with the endocardium and counter-traction can then be applied to permit a more controlled lead extraction. Since the teeth on the tight rail sheath are concealed, counter-traction can be safely applied without risk of direct trauma to the endocardium.
Outcomes of lead management interventions can be divided into two phases: Procedure and postprocedure. It considers both the success of the procedure and procedure-related complications over a predefined period. Accordingly, lead intervention procedure outcomes are defined by the extraction procedure success and where applicable, complications that occur during the extraction procedure, the inpatient hospitalization period, and the follow-up period.[9],[10]
Complications that can trigger medical attention following discharge include upper extremity swelling due to venous thrombosis; recurrent infection, particularly in patients who underwent incomplete extraction for CIED infection; new pocket or systemic infection; lead perforation; lead dislodgement; heart failure; symptoms associated with tricuspid valve injury; pneumonia; and complications from thromboembolism, including pulmonary embolism.
Our patient cohort consisted of a varied group, including high-risk case of ARVD. It exhibited devices with leads in situ for a long period, particularly prone to calcification and fibrosis, a combination of pacing and defibrillator leads, endocardial and epicardial leads with greater concerns regarding perforation of more tortuous and fragile coronary sinus branches. With this lead locking tight rail device, not only was it possible to extract chronically implanted leads safely, but it also enabled the preservation of vascular access by recanalization of long occlusions. There were no major complications observed over a follow-up of 1 year.
In our sick and high-risk patient group, the tightrail system has proved to be clinically safe and effective in experienced hands. Its lower cost compared to powered tools like lasers makes it a lucrative option for lead extraction at government setup. The mechanical nature of this tool makes it more prone to procedural complications in the setting of multiple, severe calcific adhesions with tortuous collaterals. However, more data and reporting of outcomes are required.
| Summary and Conclusions | | |
Leads <1-year-old can be safely removed with standard tools. However, when a chronically implanted cardiac device must be removed; with due procedural diligence, experts can use specialized tools and techniques to extract the device and leads safely and effectively. As lead extraction becomes more common and more research in the area is performed, this procedure will continue to evolve and improve. Physicians should discuss the risks and benefits with their patients before the procedure.
We here have reported the successful use of tight rail mechanical dilator sheath as an effective first-line method for chronically implanted CIED leads. It has added benefit of successful recanalization of long venous occlusions. Continued further study is required to evaluate the efficacy and risks of the lead locking tight rail device in comparison with other techniques.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
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| 3. | Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH 3 rd, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: This document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009;6:1085-104. |
| 4. | Johansen JB, Jørgensen OD, Møller M, Arnsbo P, Mortensen PT, Nielsen JC. Infection after pacemaker implantation: Infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J 2011;32:991-8. |
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| 6. | Maytin M, Wilkoff BL, Brunner M, Cronin E, Love CJ, Grazia Bongiorni M, et al. Multicenter experience with extraction of the Riata/Riata ST ICD lead. Heart Rhythm 2014;11:1613-8. |
| 7. | Di Monaco A, Pelargonio G, Narducci ML, Manzoli L, Boccia S, Flacco ME, et al. Safety of transvenous lead extraction according to centre volume: A systematic review and meta-analysis. Europace 2014;16:1496-507. |
| 8. | Buiten MS, van der Heijden AC, Schalij MJ, van Erven L. How adequate are the current methods of lead extraction? A review of the efficiency and safety of transvenous lead extraction methods. Europace 2015;17:689-700. |
| 9. | Sohail MR, Uslan DZ, Khan AH, Friedman PA, Hayes DL, Wilson WR, et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol 2007;49:1851-9. |
| 10. | Tarakji KG, Wazni OM, Harb S, Hsu A, Saliba W, Wilkoff BL. Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: The impact of the infection type and the presence of vegetation on survival. Europace 2014;16:1490-5. |
[Figure 1], [Figure 2]
[Table 1]
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