Tips for Establishing a Successful Lead Management Program at a Community Hospital

Cardiac implantable electronic devices (CIEDs) such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) remain an important part of the therapeutic armamentarium in cardiac electrophysiology (EP). CIEDs can be implanted using a submuscular or subcutaneous approach to correct a fast or slow heart rhythm, terminate a life-threatening arrhythmia, or improve hemodynamic function.

However, complications associated with CIED use can occur. A lead management program can be established to provide comprehensive care of CIEDs. In May 2020, we created a lead management program at our small community hospital located in a rural area. In this article, we describe our recommendations and best practices for a new lead extraction and management program.

Benefits of a Lead Management Program

As the number of patients with CIEDs increases due to longer life expectancy, better access to health care, and improved technologies,^1-3 lead management has become more integral. A collaborative effort between services is the cornerstone for safe and successful lead management. Several clinics offer device implantation but require the assistance of our specialists for advanced care. As the closest referral center is 2-3 hours away, having a comprehensive lead management program in the community is also convenient and beneficial for patients with a malfunctioning lead or device. A lead management program can shorten the waiting time from a referral or travel standpoint, increase revenue for the hospital, and improve patient satisfaction.

A Team Approach

Our lead management program is a collaborative effort, encompassing the device clinic, EP lab, cardiothoracic surgery, anesthesiology, radiology, vascular surgery, industry representatives, and perfusionists. Lead management starts with detection of device issues in the clinical setting, including the emergency department. Industry representatives are also often the first to encounter device notifications, so it is important to discuss goals and strategies of care with them as well. Device rounds offer educational opportunities for our staff to stay updated on the latest technologies and improve quality of care.

During lead extraction, it is common to have a backup cardiothoracic surgery team for emergency situations. The ideal strategy is to have a cardiothoracic surgeon present during procedures as much as possible. Complications associated with lead extraction procedures can be life-threatening⁴ or require time-sensitive interventions such as sternotomy or thoracotomy. Having both the cardiothoracic surgeon and operating room (OR) staff present in these situations is critical. A discussion with the cardiothoracic surgery team and hospital administration should be made to help make this arrangement possible. A compensation model should also be in place with the cardiothoracic surgery team. We have a 50% shared relative value unit with our cardiac surgeons for lead extraction procedures. It cannot be overstated how much we value our cardiothoracic surgery team as a part of the lead management program.

Having a designated team and workflow in place for lead extraction procedures helps accelerate procedural setup, prevent missing steps, and minimize error. To ensure safety, everyone should know their responsibility in an emergency situation.

Our sonography technicians are trained in the use of transesophageal echocardiography (TEE) to confirm the presence of pericardial or pleural effusion.⁵ There is also increased use of intracardiac echocardiography (ICE) during transvenous lead extraction to visualize and survey for possible complications.⁶ TEE is our preferred imaging modality. In our experience, we find that adjusting the view on ICE when changing the location from the pocket site to the groin can be cumbersome without an assistant. However, we also understand that anesthesiologists should focus on the single task of hemodynamic monitoring with prompt management of the patient and that distracting that key task with TEE probe manipulation may compromise their duty. We believe our setup is unique in that anesthesiologists are able to focus on their job rather than doing both TEE- and anesthesiology-related tasks. Clear verbal communication between the TEE sonographer, the operator, and anesthesiology team is crucial to confirm pathology and quickly decide on next management steps to ensure optimal outcomes.    

Finally, the hospital administrative team should be kept informed on the latest lead extraction outcomes data for the program. We meet with them regularly to discuss patient morbidity and mortality, procedural volume, and areas of improvement. This has helped to facilitate growth of the program, especially in the beginning stages, when procedural volume is still low and a small number of complications could affect the morbidity/mortality rate of the program.   

Shared Decision-Making

A shared decision-making model between the physician and patient ensures effective communication and helps the patient make informed health care decisions. This can be achieved with a detailed discussion about available treatments and the short- and long-term risks and benefits of each option. Certain indications for lead extraction, such as infection, are often straightforward. However, the decision to extract or abandon leads in “non-class I” indications can sometimes be complicated.¹ Bias toward performing lead extraction should be kept in mind to ensure that the decision is mutual, with sufficient evidence to support all viable options for patients. In nonemergent situations, our lead management program ensures there is an adequate amount of time for patients to review and discuss each option in detail. Pamphlets and resources that include details of the procedure and available options are an effective educational tool for our patients. We create a document explaining the options that were discussed with the patient, the risks and benefits of each option, and the final decision reflecting the shared decision-making process. This detailed documentation is used to prevent medical liability.

Preparation and Review

Device information such as the number and detail of existing or abandoned leads, special precautions for certain lead models, and other details of the device should be thoroughly reviewed before the patient’s first visit. A comprehensive review is critical and allows us to organize options for management, including the risks and benefits of each option. If the patient ultimately requires an invasive procedure such as lead extraction, our next step is preprocedural preparation. While clinical studies have defined the factors that contribute to high morbidity and mortality of lead extraction procedures,⁷ it is reasonable to assume all lead extractions have the potential of being high risk. As a result, clinicians should not trivialize discussions regarding the risks of lead extraction, regardless of the complexity level. Collaborating with industry representatives on lead extraction cases has also been helpful for us. In our program, we perform an extensive review with all parties regarding the details of the device and leads that we will be working on, the possible challenges we may come across, available options based on the individual clinical scenario, and the backup plan in case of complication or procedural failure. We find this preparation helps tremendously during the case, especially when the procedures do not go as planned or when emergency decisions need to be made. Timeout at the beginning of each procedure is also a critical step. Simple preparation includes having different types of sternal saws available with a full battery, blood products in the room, a cardiopulmonary bypass machine, and all mechanical or laser tools including a snaring system. This dedicated timeout for all teams (EP, cardiac surgery, perfusionist, and anesthesiology) is part of our routine practice.

Our staff also regularly practices clinical scenarios that require an emergent sternotomy. Every staff member is aware of their duty and can act immediately without instruction. This strategy helps to minimize chaos and duplicate work during a critical time. Our lead extractions take place in the hybrid OR; lead extraction procedures should occur in the OR or hybrid OR so relocation of the patient is not required in an emergency situation. The room should have sufficient space to allow for sternotomy or thoracotomy and cardiopulmonary bypass to be performed. Growing evidence from high-volume institutes with experienced operators has demonstrated that lead extraction can be performed safely in a standard EP room.⁸ However, for new lead extraction programs, we recommend that lead extraction procedures take place in an OR or hybrid room only.

Additionally, we find that prioritizing cases each day in the number and complexity of cases also contributes to success. We typically schedule the highest risk case as the first procedure of the day. We set only 2 elective cases (maximum of 3) each day to allow for adequate procedure time and turnover. Based on OR availability and surgeon coverage, we also schedule a dedicated extraction day (biweekly or monthly) for our elective cases.

Learning From Others

We feel fortunate that knowledge of advanced lead extraction techniques is now commonly and easily shared among professionals in the field. Social media and medical conferences offer a great way to share and discuss challenging cases. New lead extraction programs should partner with mentors to discuss challenging cases and share their experience. In this way, new lead management programs can assure patients that they will receive the best care, either through their current institution or through a referral to another program. In addition, we encourage physicians and staff at newer lead management programs to visit high-volume centers to learn about different techniques that can be applied to their program.

Safety and Competency

Safety is a top priority when establishing a lead management program. Becoming an experienced, high-volume program with a well-established referral network is the end goal. High-volume centers typically experience better outcomes compared to low-volume centers.^1-3 When setting up a new lead extraction program, we recommend considering the difficulty or complexity level of the first few cases, as morbidity and mortality rates should be kept as low as possible in the first few years of practice. The level of complexity can gradually be escalated as the operator becomes more comfortable, but this may require patience and the referral of more complicated cases to higher volume institutes. For the first 6 months of our program, we only performed lead extractions in which the leads were less than 5 years old. We then slowly moved on to more complex cases. We currently perform about 2-4 lead extractions per month. We also refer patients such as those with complex congenital heart defects to specialized centers.^1,3

The low morbidity and mortality rate of the program should be used to justify the success of the program rather than volume. In lead extraction, a minimum of 15 procedures (extracting at least 20 leads) is required each year to maintain competency.³ However, not all malfunctioned leads need to be extracted. Class I indications for lead extraction should be used for decision-making. Alternative methods for eliminating risk should be kept in mind for other levels of indication in lead extraction. Also, knowing when to abort the extraction is as important as the lead extraction itself. Even for Class I indicated patients in whom lead extraction will be the most beneficial, there is still the potential for significant risk, so clinicians should be transparent with patients in estimating the probability of success or failure based on their level of experience. Patient referral to high-volume centers is always appropriate and in the best interest of the patient. Establishing a network with experienced operators to improve knowledge and skill can be beneficial in the long term for a lead management program.

Summary

In this article, we have provided our tips for setting up a safe and successful lead extraction program for our community. Other hospitals interested in developing a lead management program should assess and adjust these details according to their own resources and limitations. We hope that by sharing our experience of establishing a lead management program at our small community hospital, that we can inspire others to develop a similar program in the future. 

Disclosures: The author has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Akrawinthawong has no conflicts of interest to report regarding the content herein.   

References

1. Writing Committee Members, Silka MJ, Shah MJ, et al. 2021 PACES expert consensus statement on the indications and management of cardiovascular implantable electronic devices in pediatric patients: executive summary. Heart Rhythm. 2021;18(11):1925-1950. doi:10.1016/j.hrthm.2021.07.051

2. Love CJ. Lead management and lead extraction. Card Electrophysiol Clin. 2018;10(1):127-136. doi:10.1016/j.ccep.2017.11.013

3. Bongiorni MG, Burri H, Deharo JC, et al. 2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS. Europace. 2018;20(7):1217. doi:10.1093/europace/euy050

4. Hussein AA, Tarakji KG, Martin DO, et al. Cardiac implantable electronic device infections: added complexity and suboptimal outcomes with previously abandoned leads. JACC Clin Electrophysiol. 2017;3(1):1-9. doi:10.1016/j.jacep.2016.06.009

5. Nowosielecka D, Polewczyk A, Jachec W, et al. Transesophageal echocardiography for the monitoring of transvenous lead extraction. Kardiol Pol. 2020;78(12):1206-1214. doi:10.33963/KP.15651

6. Sadek MM, Cooper JM, Frankel DS, et al. Utility of intracardiac echocardiography during transvenous lead extraction. Heart Rhythm. 2017;14(12):1779-1785. doi:10.1016/j.hrthm.2017.08.023

7. Jachec W, Polewczyk A, Polewczyk M, et al. Risk factors predicting complications of transvenous lead extraction. Biomed Res Int. 2018;2018:8796704. doi:10.1155/2018/8796704

8. Issa ZF. Transvenous lead extraction in 1000 patients guided by intraprocedural risk stratification without surgical backup. Heart Rhythm. 2021;18(8):1272-1278. doi:10.1016/j.hrthm.2021.03.031