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Intersections in the Management of Heart Failure, Electrophysiology, and Cardiac Implantable Device Management
Complex cardiac device and lead management is required for the delivery of high-quality care to patients with heart failure (HF). Contemporary patients with HF are increasingly older and medically complex, requiring careful decision-making regarding cardiac implantable electronic device (CIED) management that begins with initial consideration for hardware implantation and lasts throughout the patient’s lifetime. As with most medical considerations, management of a CIED is not a one-time event; it must be revisited repeatedly as changes occur with the patient’s underlying condition, preferences, and goals. Herein, we present a case of a complex patient with HF with multiple cardiovascular conditions requiring CIED system replacement, and highlight how prompt evaluation and well-established lead management protocols contribute to a successful outcome.
Case Presentation
Initial Presentation
A 59-year-old female presented to the electrophysiology (EP) service during an admission for decompensated HF in August 2019. She had a long history of nonischemic cardiomyopathy that was likely secondary to remote viral myocarditis with left bundle branch block (QRS 170 ms) and chronically reduced left ventricular ejection fraction (LVEF) (~45%) despite maximally tolerated medical therapy. She also had a history of tachycardia-bradycardia syndrome, and her presentation was complicated by rapidly conducted atrial fibrillation (AF) (Figure 1). Her LVEF had diminished to 29%. After considering various approaches to treating her HF and AF, implantation of a cardiac resynchronization therapy with defibrillator (CRT-D) device was pursued for primary prevention of sudden cardiac death and electrical resynchronization. Venous anatomy for biventricular CRT placement was favorable, but LV capture thresholds were modestly elevated. Nonetheless, with restoration and maintenance of sinus rhythm and consistent delivery of CRT, LV dimensions improved, systolic function recovered, and HF symptoms resolved over the next few weeks and months (Figure 2). AF did not recur during this period of recovery.
Follow-up Presentation
Unbeknownst to the EP service, the patient was admitted in the spring of 2021 with an episode of lower extremity cellulitis complicated by bacteremia with Group B beta-hemolytic streptococci that resulted in osteomyelitis of a toe, requiring amputation. In the spring of 2022, she again presented with signs and symptoms of systemic infection including fever, nausea, and vomiting. Workup demonstrated recurrent cellulitis of the right lower extremity and magnetic resonance imaging findings were suggestive of osteomyelitis. She was treated with oral antibiotics and discharged home. Within 3 weeks, she returned with recurrent signs and symptoms of infection and blood cultures positive for methicillin-sensitive Staphylococcus aureus. Transesophageal echocardiography (TEE) demonstrated an independently mobile mass on the right ventricular (RV) lead of her CRT-D consistent with lead-related endocarditis. Recommendation guidelines were discussed,1,2 and the patient agreed to proceed with system removal. Preprocedural computed tomography imaging with contrast3,4 demonstrated patency of the subclavian vein and superior vena cava (SVC) and that the terminal location of each lead was not extramyocardial.
System Removal
The procedure was scheduled in the hybrid operating room (OR), a shared facility for cardiovascular procedures with state-of-the-art fluoroscopic imaging where conversion to open heart surgery with cardiopulmonary bypass is available when needed. Cardiothoracic surgery assessed the patient to be a reasonable candidate for rescue sternotomy in the case of serious complication and remained on standby. General anesthesia was induced with endotracheal intubation aided by invasive monitoring via radial arterial line. A TEE probe was advanced to the esophagus, where a baseline examination confirmed the presence of an RV lead vegetation, no pericardial effusion, and moderate tricuspid regurgitation.
After standard prepping and draping, large venous access in the groin was established for (1) an SVC occlusion balloon, which was prepped and staged in the SVC and then pulled back to the inferior vena cava; and (2) rapid volume resuscitation in case of complication. The left-sided pocket was entered, and the device and proximal leads were externalized without gross evidence of pocket infection. The leads were disconnected from the generator, and using a standard stylet, retraction of the active fixation helix on the right atrial (RA) and RV leads was attempted without success. A locking stylet was passed down each lead and the locking mechanism was deployed. Simple traction failed to release the leads from binding fibrosis. Using the laser sheath (GlideLight Laser Sheath, 14 Fr, Philips), each of the leads was removed in its entirety. Significant binding was noted at the junction of the innominate and SVC, and sustained traction was required to release the RV lead tip from the RV septum (Video 1). Lead tips and fluid from the device pocket were sent for gram stain and culture, but no organisms were isolated. TEE imaging throughout the procedure confirmed no pericardial fluid collection or significant change in tricuspid regurgitation.
Video 1. Sustained traction to release the RV lead tip from the septum. When the active fixation mechanism does not retract at the time of lead extraction, sustained traction and patience are key in nontraumatic release of the lead.
Post-extraction Follow-up
Without evidence of ongoing active infection, the patient underwent contralateral reimplantation of a new CRT device 5 days after system removal. She was discharged 2 days later with 4 weeks of intravenous antibiotics planned.
Discussion
In this case report, CIED extraction is highlighted as a critical component of treatment for device-related endocarditis. System removal offers an opportunity for cure that may otherwise be unlikely. This is exemplified by evidence of improved mortality associated with prompt system removal vs more conservative management strategies.5 Prompt evaluation of the patient was critical in this case, as initial presentation with systemic infection in the form of early osteomyelitis was an indication of CIED-related infection. Emerging strategies using artificial intelligence hold promise for improving treatment of CIED patients admitted to the hospital with bacteremia by allowing for earlier identification of at-risk patients to the lead management team.6,7
Once CIED-related infection is identified, specialized equipment and expertise is required for removal of any lead in situ for more than a year. Lead extraction procedures require cooperation and coordination among a variety of stakeholders across regions, health systems, and facilities. For health care facilities offering lead extraction, institutional protocols are necessary to maintain safety and avoid risk of SVC perforation. The following tips are our recommendations for improving the safety of lead extraction.
First, an appropriate location should be designated for lead extractions. Consideration should be based on a number of factors, including room size to accommodate personnel and equipment to avoid having to move an unstable patient in case of emergency. Appropriate imaging capabilities such as high-quality fluoroscopy should also be available to help reduce radiation exposure to patients and staff. When available, an ideal location is a hybrid OR with the capability to accommodate both EP and cardiothoracic surgery; such facilities are generally shared among various clinical services.
Second, procedural safety protocols should be established and consistently followed. Examples employed at our institution include identifying and confirming the availability of a cardiac surgeon on standby for the entirety of the extraction procedure who is (1) in the building, (2) briefed on the patient and agreeable to providing surgical backup as needed, and (3) not scheduled to be operating elsewhere. Additionally, 4 units of crossmatched packed red blood cells should be available in the procedure room during the period of extraction. The staging of an SVC occlusion balloon (eg, Bridge Occlusion Balloon, Philips) provides an added layer of protection. In the case of SVC tear, the balloon can be inflated at the RA/SVC junction to tamponade an SVC tear and help keep the field free of blood should emergency sternotomy be needed. Anesthesia should also be carefully considered for each case; when transesophageal imaging is performed as part of the procedure, general anesthesia offers some benefits.
Finally, a humble and ongoing assessment of performance must be integrated into any lead extraction program. This ongoing assessment includes systematic tracking of procedures, related complications, and specific operator volume. This allows for an honest appraisal of team readiness for increasingly complex cases based on lead and patient factors, and encourages the development of productive partnerships between less and more experienced centers.
Summary
CIEDs play a critical role in the management of HF patients. Device management is often complex and may change according to patient preference and clinical status. CIED-related infection is associated with significant morbidity and reduced survival, and can be devastating in a HF patient. Strategies that reduce the risk for infection are essential. Procedures should be in place to facilitate expeditious management with a focus on system extraction when necessary.
For more information, contact the authors
Dr Zeitler @EmilyZeitler and Dr Kwaku @ECGMD on Twitter, or join the conversation at #Treat2BeatCIEDInfection
Disclosures: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Zeitler reports consulting fees from Biosense Webster, Medtronic, Sanofi, Pfizer, Boston Scientific, and Echo IQ; Dr Zeitler also reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events, and support for attending meetings and/or travel from Medtronic. Dr Grove and Ms Chase have no conflicts of interest to report regarding the content herein. Dr Kwaku reports consulting fees from Biosense Webster and support for attending meetings and/or travel from Medtronic.
References
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5. Pokorney SD. Low rates of guideline-directed care associated with higher mortality among patients with cardiac implanted electronic device infection. Paper/poster presented at: American College of Cardiology; April 3, 2022; Washington, DC.
6. Sifrig LA, Taylor LM, Rousseau LA, et al. B-PO03-005: Automating and expediting identification of cardiac impantable electronic device infections. Heart Rhythm. 2021;18(8):S190-S191. doi:10.1016/j.hrthm.2021.06.481
7. Mull HJ, Stolzmann KL, Shin MH, et al. Novel method to flag cardiac implantable device infections by integrating text mining with structured data in the Veterans Health Administration’s electronic medical record. JAMA Netw Open. 2020;3(9):e2012264. doi:10.1001/jamanetworkopen.2020.12264
