Lead Management is More Than Just Extraction

Many factors have led to a dramatic expansion in the implantation of cardiac rhythm management devices such as pacemakers (PCM), implantable defibrillators (ICD) and cardiac resynchronization therapy devices (CRT). This includes an aging population, expanded indications for ICD therapy and the role of CRT in the management of heart failure.^1-4 Therefore, a higher percentage of patients have implanted devices. While usually functioning without issues, physicians must be aware of potential device-related complications. This includes even those physicians not specifically following “the device.” In addition, those physicians responsible for “following” cardiac rhythm management devices must understand the management of these complications. Transvenous lead-related issues can include dislodgement, malfunction, infection or venous occlusion. Properly managing these issues can be critically important and even lifesaving for these patients. ^5,6 The case presented here represents a failure of proper lead management, resulting in over a decade-long saga for the patient involved.

Case History

The patient is a 76-year-old female who presented for infectious disease consultation for episodic shaking chills, rigors and low-grade fevers. The patient’s prior history included peripheral neuropathy and hypertension. For symptomatic bradycardia, she underwent right-sided pacemaker placement in 1994. There were continuing issues of pocket infection resulting in multiple pocket revisions, and in 2000, the device was removed. The leads were cut and allowed to retract. A new pacing system was placed on the left side. In 2002 the patient first began having symptoms of shaking chills and low-grade fevers (99-100ºC), although her temperature would occasionally spike to 102 ºC. There was a question of an elevated white blood cell count (WBC) at the time, but according to the patient, this resolved in two to three months. She presented again in June 2007 with recurrent shaking chills and low-grade fevers. Her WBC was found to be 19-22,000. She was treated for a urinary tract infection (UTI) with ciprofloxacin, and showed some improvement. The shaking chills returned in August 2007, and she was once again treated with ciprofloxacin for a presumed UTI. In November and December 2007 she was again treated for a UTI with persistent elevated WBC and no improvement in symptoms. In January 2008 a cystoscopy demonstrated ineffective bladder contractions. No intervention was performed. In April 2008 she was admitted again for shaking chills to an outside hospital and treated with a “stronger antibiotic.” Ultimately, her cardiologist observed her rigors. He referred her for an infectious disease consultation. Blood cultures were negative and a transesophageal echocardiogram (TEE) performed on April 22, 2008 at an outside institution revealed a “normal” tricuspid valve. A urine culture was positive for enterococcus and she was treated for six days with vancomycin. Repeat blood cultures, urine studies and bartonella serologies were negative. A chest and abdominal CT revealed bilateral pulmonary emboli, and the patient was started on anticoagulation. Lower extremity duplex ultrasounds were normal. Repeat blood cultures remained negative, but she was again admitted to an outside hospital on June 11, 2008 for recurrent fevers. A repeat TEE (Figure 1) demonstrated multiple pacing leads in the lower right atrium, a 0.5 x 0.5 cm mobile density on the tricuspid valve, and moderate tricuspid regurgitation. There was also moderate tricuspid stenosis thought to be due to the leads obstructing flow through the lower right atrium. The patient was transferred to the Brigham and Women’s Hospital for treatment. Her chest x-ray on admission can be seen in Figure 2. The proximal ends of the right-sided atrial and ventricular leads had retracted into the vasculature and can be seen in the superior vena cava (SVC) entangled with the left-sided leads. The loops of redundant leads can be seen in the lower right atrium, responsible for the “functional” tricuspid stenosis. The Arrhythmia Service was consulted, and the patient was taken to the operating room for a lead extraction procedure. Extraction Procedure Given that two leads had retracted into the vasculature, the procedure was planned for both a superior and inferior (femoral) approach. Fortunately the patient was not pacemaker-dependent and therefore did not require temporary pacing. Access was gained through the right femoral vein with a short 8 French (Fr) sheath. The left-sided system was approached first. The pocket was opened and the pacemaker was removed. The leads were freed from scar tissue in the pocket and the anchors were removed. The leads were cut and locking stylets (LLD EZ™, Spectranetics Inc., Colorado Springs, Colorado) were placed distally in both the atrial and ventricular lead; #5 silk sutures were tied to the insulation of both leads. A 14 Fr Spectranetics laser sheath was employed to free the leads from encapsulating scar tissue in the vasculature and heart (Figures 3A-3F). The atrial lead was approached first, and extensive binding between the newer left-sided leads and the abandoned leads was present (Figure 3B). The laser sheath effectively freed the leads from binding, and both were successfully removed with counter traction. The abandoned leads were then approached (Figures 4 A-4D). The sheath in the right femoral vein was exchanged for a 16 Fr “femoral workstation” (Cook Vascular, Leechburg, Pennsylvania). To “pull” the proximal ends of the abandoned leads down to the inferior vena cava (IVC) from the SVC, a steerable ablation catheter (Blazer II, Boston Scientific, San Jose, California) was employed, as can be seen in Figure 4A. A gooseneck snare was then advanced over the free ends of both the atrial and ventricular leads (Figure 4B). The atrial lead was successfully removed with traction, but the ventricular lead was disrupted. A “needle-eye” snare (Cook Vascular) was then inserted to engage the remainder of the ventricular lead conductor (Figure 4C). The connection between the conductor and the distal electrode ruptured. The entire conductor was removed and the distal electrode was left embedded in the ventricular myocardium. The patient tolerated the procedure well without complication. Cultures of lead material grew coagulase negative staphylococcus and the patient was treated with a 6-week course of intravenous vancomycin and ceftriaxone. Her WBC normalized, and she has had no further rigors or fevers. Repeat blood cultures (off antibiotics) remain negative.

Discussion

This case demonstrates two important clinical issues that arise far more often than they should: a failure to appropriately manage the initial device infection, and a failure to recognize an occult, chronic device infection. The decade-long saga this patient endured could have been avoided if the initial device-related infection was appropriately managed. Infections involving implanted hardware can be very difficult, if not impossible, to treat effectively without removal of the hardware. Studies have demonstrated significant mortality in device-related infections not treated with device removal. ^7-9 In this case, persistent pacemaker pocket infections were inadequately treated, first with repeated attempts of pocket revisions, and ultimately with removal of the device but abandonment of the leads. Although some studies have suggested the abandonment of leads is a reasonable approach, others have demonstrated significant complications with this approach. ^7-15 The abandonment of non-infected leads needs to be considered on a case-by-case basis; however, infected leads should never be abandoned. In addition, abandoned leads should never be cut without securing them to the pocket. This approach runs the risk of the leads retracting into the vasculature, which can result in the proximal lead end free in the vasculature and/or heart. There have been case reports of life-threatening arrhythmias due to the mechanical irritation of these leads. ^5,6 In this presented case, the leads were cut and intentionally allowed to retract due to the persistent pocket infection. This resulted in functional tricuspid stenosis and persistent endocarditis with septic pulmonary emboli. However, the development of tools specifically designed for lead extraction, such as locking stylets and laser sheaths, allowed for a high success and a low complication rate. ¹⁶ Therefore, lead management, especially in the presence of device-related infection, should include removal of all involved hardware, including the leads. Physicians who follow devices, but who do not practice lead extraction, should consider referral to a high-volume center.