Juan D. Garisto

Multicenter Experience With Extraction of the Sprint Fidelis Implantable Cardioverter-Defibrillator Lead

OBJECTIVES This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead. BACKGROUND The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited. METHODS We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance. RESULTS Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95% confidence interval: 1.010 to 1.061; p=0.006). There were no major procedural complications or deaths. CONCLUSIONS Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration.

Patency rates for angioplasty in the treatment of pacemaker-induced central venous stenosis in hemodialysis patients: results of a multi-center study.

While hemodialysis access ligation has been used to manage pacemaker (PM) and implantable cardioverter‐defibrillator (ICD) lead‐induced central venous stenosis (CVS), percutaneous transluminal balloon angioplasty (PTA) has also been employed to manage this complication. The advantages of PTA include minimal invasiveness and preservation of arteriovenous access for hemodialysis therapy. In this multi‐center study we report the patency rates for PTA to manage lead‐induced CVS. Consecutive PM/ICD chronic hemodialysis patients with an arteriovenous access referred for signs and symptoms of CVS due to lead‐induced CVS were included in this analysis. PTA was performed using the standard technique. Technical and clinical success was examined. Technical success was defined as the ability to successfully perform the procedure. Clinical success was defined as the ability to achieve amelioration of the signs and symptoms of CVS. Both primary and secondary patency rates were also analyzed. Twenty‐eight consecutive patients underwent PTA procedure. Technical success was 95%. Postprocedure clinical success was achieved in 100% of the cases where the procedure was successful. The primary patency rates were 18% and 9% at 6 and 12 months, respectively. The secondary patency rates were 95%, 86%, and 73% at 6, 12, and 24 months, respectively. On average, 2.1 procedures/year were required to maintain secondary patency. There were no procedure‐related complications. This study finds PTA to be a viable option in the management of PM/ICD lead‐induced CVS. Additional studies with appropriate design and sample size are required to conclusively establish the role of PTA in the management of this problem.

Management of cardiac device-related infections: A review of protocol-driven care

BACKGROUND The prevalence of cardiac device-related infections (CDIs) has mirrored the unprecedented increase in device usage. CDIs are currently one of the leading indications for extraction. Despite this, there is limited data regarding the clinical trends, management and outcomes associated with this complication. METHODS A review of a prospective registry of all patients undergoing device extraction between January 1, 2004, and June 15, 2009, at a single high-volume tertiary referral center was performed. RESULTS A total of 506 consecutive patients were identified. From these, 350 patients were identified as having a CDI (205 ICD, 145 PPM). The mean age was 69.9 ± 13.7. Although most patients presented clinically with signs of a pocket infection (PI) (42%), the most common final diagnosis was cardiac device infective endocarditis (CDIE) (57%). The two most common pathogens were methicillin-resistant Staphylococcus aureus (27%) and methicillin-resistant Staphylococcus epidermidis (23%); they accounted for 69% of all deaths. Cultures taken from pocket tissue as opposed to exudates displayed higher concordance with lead-tip cultures (56% and 31% respectively). The mean time from explantation to device reimplantation for PIs, bacteremia and CDIE was 6.7 ± 4.7, 10.25 ± 4.7 and 11.39 ± 16.6 days respectively. CONCLUSION CDIs are a serious complication associated with device usage. Diagnosis and management protocols for CDIs should feature transesophageal echocardiography; complete hardware extraction; broad-spectrum antibiotics that cover methicillin-resistant Staphylococci and cultures derived from lead-tips and preferably pocket tissue. Immediate device reimplantation is possible in noninfectious cases; several factors should be considered regarding reimplantation in cases involving CDIs.

Multicenter experience with extraction of the Riata/Riata ST ICD lead

BACKGROUND In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. OBJECTIVE Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. METHODS We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. RESULTS Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P < .0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs. 17.7% failure; P = .23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P = .01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). CONCLUSION Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.

A Novel Technique for Tethered Dialysis Catheter Removal Using the Laser Sheath

Traction and cutdown techniques can successfully remove a tunneled dialysis catheter (TDC) in a great majority of patients. However, these methods may not be successful in patients with catheters that are tethered or attached to the central veins or the atrium. A forceful application of traction can lead to catheter breakage with subsequent retention of the broken piece and carries a potential risk of vascular and atrial wall avulsion. Open thoracotomy has been employed to remove an attached TDC. However, this procedure is invasive and bears a significant morbidity. This report presents three cases of tethered TDCs that underwent laser sheath extraction. The TDCs had been in place for an average of 26 months. The patients underwent initial unsuccessful removal attempt using the traction method with surgical exploration all the way to the venotomy site. The laser technique that is used to remove pacemaker/implantable cardioverter defibrillator leads was then applied to these stuck catheters. All three catheters were successfully removed without any damage to the catheter, central veins, or the right atrium. There were no retained catheter fragments left in the central veins or the atrium. One patient demonstrated a significant thrombus that extended from the tip of the catheter all the way to the right ventricle. The external sheath of the laser device successfully aspirated the thrombus. There were no procedure‐related complications. In this small series, a laser sheath successfully extracted tethered dialysis catheters. The study found the procedure to be effective, easy to perform, and minimally invasive. We suggest that this approach be considered for the removal of tethered catheters that cannot be removed using traditional approaches.

Epicardial Cardiac Rhythm Devices for Dialysis Patients: Minimizing the Risk of Infection and Preserving Central Veins

Transvenous leads of cardiac rhythm devices (CRDs) are known to cause central stenosis and are vulnerable to contamination during hemodialysis access‐related bacteremia. In this retrospective study, nine consecutive chronic hemodialysis patients with transvenous CRD infection due to dialysis access‐related bacteremia and recurrent central stenosis are presented. Four patients with tunneled hemodialysis catheters (TDCs) and three with arteriovenous grafts experienced access‐related bacteremia that spread to the transvenous CRD. Two patients required repeated angioplasty procedures (less than 3 months apart) for central venous stenosis. Transvenous CRD was removed and replaced with an epicardial system in all. One patient with TDC switched to peritoneal dialysis and did not experience infection of the epicardial system despite two episodes of peritonitis. The remaining TDC (n = 3) and graft patients (n = 3) received a new TDC after the resolution of bacteremia. While all six experienced on average 1.5 episodes of catheter‐related bacteremia (average follow‐up = 14.5 months), none developed infection of the epicardial system. The patients with central stenosis have required only one angioplasty each for the past 8 and 6 months. To the best of our knowledge this is the first study to suggest that an epicardial approach might be a preferred method over transvenous leads for chronic hemodialysis patients.

Laser Lead Extraction in the Octogenarian Patient

Background— In the United States, patients aged >75 years are the most rapidly growing segment in the population, with an expected increase of 126% by 2050. These patients account for >70% of the pacemakers and up to two thirds of the implantable cardioverter-defibrillators implanted annually. Our aim was to explore the clinical outcomes of device complications in the octogenarian population. Methods and Results— We performed a retrospective chart review of 506 patients undergoing laser lead extraction from January 2004 to September 2009. This population was divided into the following 2 groups based solely on age: octogenarians and nonoctogenarians. These 2 groups were compared on the basis of several characteristics and clinical outcomes. There were 118 patients in the octogenarian group (78 men) and 388 in the nonoctogenarians group (301 men) aged 85±3.8 and 64.2±12.4 years, respectively. A total of 253 leads (atrial, 99; ventricular, 145; coronary sinus, 9) were removed from the patients in the octogenarian group, and 814 leads (atrial, 295; ventricular, 442; coronary sinus, 77) were removed from the patients in the nonoctogenarian group. The main indication for extraction for both groups was infection. The lead implant duration was 59.6±52.8 and 38.6±43.9 months for octogenarians and nonoctogenarians, respectively. There was no significant difference with respect to the proportion of minor (P=0.65), major (P=0.56), and total (P=0.50) complications. Conclusions— Laser lead extraction is demonstrated to be a safe and effective treatment method in octogenarian patients with multiple comorbidities.

Contamination of Transvenous Pacemaker Leads Due to Tunneled Hemodialysis Catheter Infection: A Report of 2 Cases

Catheter-related bacteremia is a frequent complication associated with the use of tunneled hemodialysis catheters. Catheter-related bacteremia can lead to metastasis of infection to other sites. This article presents 2 patients with transvenous pacemakers (placed >2 years ago) who were receiving long-term hemodialysis therapy using tunneled hemodialysis catheters. Both were admitted to the hospital with catheter-related bacteremia. Blood cultures showed methicillin-resistant Staphylococcus aureus (MRSA) in both cases. Transesophageal echocardiography was negative for the presence of valvular endocarditis, but showed lead-associated vegetation in both cases. Intravenous antibiotic therapy was initiated, and both the tunneled hemodialysis catheters and cardiac devices were removed by a cardiothoracic surgeon. The catheter tip and leads cultures showed MRSA in both cases. After resolution of bacteremia, both patients received an epicardial cardiac device. Antibiotic therapy was continued for 6 weeks. Renal physicians providing dialysis therapy should be aware that catheter-related bacteremia could cause contamination of transvenous pacemaker leads. Because catheter-related bacteremia is a frequent complication, epicardial leads might be considered as an alternative route to provide cardiac support to catheter-consigned patients. Epicardial leads do not navigate through the central veins, lie in the path of blood flow, or cause central venous stenosis.

Arteriovenous dialysis access-associated transvenous pacemaker infection

Pacemaker (PM), implantable cardioverter defibrillator and cardiac resynchronization therapy devices also provide support to chronic hemodialysis patients with cardiac rhythm abnormalities. However, these devices can get infected. In general, device infection is either primary or metastatic spread from a distant source. Arteriovenous grafts are commonly used to provide dialysis therapy. Compared to a fistula an arteriovenous graft runs a higher risk of infection. In this analysis, we report 2 chronic hemodialysis patients who have been successfully receiving dialysis through an arteriovenous graft for approximately 2 years. Both had had a PM device for about the same duration. Access infection necessitated surgical removal of the arteriovenous graft in these patients. However, due to bacteremia (methicillin-resistant Staphylococcal aureus (MRSA)), infection spread to involve the transvenous PM leads in both patients. In 1 patient the infection also involved the PM pocket. Lead and wound culture confirmed MRSA in both patients. PM device and leads were removed in both patients. After the resolution of bacteremia, both patients received an epicardial pacemaker. None of the patients had valvular endocarditis. While dialysis was provided with a catheter, an arteriovenous fistula was planned. In conclusion, contamination of the transvenous PM device can occur due to hematogenous spread of infection from an infected arteriovenous graft. Epicardial instead of a transvenous PM might be the better option for such patients to provide long-term cardiac rhythm support.

A Novel Retrograde Laser Extraction Technique Using a Transatrial Approach: An Alternative for Complex Lead Extractions

Background— The use of percutaneous lead extraction techniques in a patient with extracardiac or protruding atrial leads could have disastrous consequences. Traditionally, the management of these patients has included a median sternotomy. We describe a minimally invasive technique that involves a transatrial, retrograde laser lead extraction using a video-assisted thoracoscopic approach. Methods and Results— Between January 2004 and June 2009, 14 patients with severed leads at the clavicle and extracardiac leads or lead-caused erosions of the atrial wall were identified through chest radiograph and CT scan. There were 9 men and 5 women aged 19 to 91 years (mean age, 69.71±20.67 years). Ten devices were pacemakers, and 4 were defibrillators. Indications for extraction were 12 infections and 2 malfunctions. Mean ejection fraction was 42±17.67% (range, 10% to 65%). Time of implanted leads was 93.69±51.88 months (range, 33 to 213 months). Laser sheaths size were 12 F (7.1%), 14 F (85.7%), and 16 F (7.1%). A right-side thoracoscopy was performed under general anesthesia. A retrograde laser sheath maneuver was performed, freeing the lead from any adhesions. The lead was removed and the incision closed. One patient experienced a pleural effusion. There was no mortality, and all patients were alive and well at 1-month follow-up. Conclusions— Transatrial, retrograde laser lead extraction is a safe and effective procedure. This procedure may provide an excellent alternative to open sternotomy.