Transvenous Lead Extraction in the Left Ventricular Assist Device Patient.

The population of patients with advanced heart failure continues to increase steadily as does the need for mechanical circulatory support. Combination therapy with left ventricular assist devices (LVADs) and cardiovascular implantable electronic devices (CIEDs) is unavoidable. CIED complications in patients with LVADs are common and often necessitate device system revision and transvenous lead extraction. Despite this, management recommendations are limited, and guidelines are lacking.

Percutaneous management of superior vena cava syndrome in patients with cardiovascular implantable electronic devices.

BACKGROUND: There is no consensus regarding the optimal management of cardiovascular implantable electronic device (CIED)-related superior vena cava (SVC) syndrome. OBJECTIVE: We report our experience with transvenous lead extractions (TLEs) in the setting of symptomatic CIED-related SVC syndrome. METHODS: We reviewed all TLEs performed at a high-volume center over a 14-year period and identified patients in which TLE was performed for symptomatic SVC syndrome. Patient characteristics, extraction details, percutaneous management of SVC occlusions, and clinical follow up data were analyzed. RESULTS: Over a 14-year period, more than 1600 TLEs were performed. Of these, 16 patients underwent TLE for symptomatic SVC syndrome. The mean age was 53.1 ± 12.8 years, and 9 (56.3%) were men. Thirty-seven leads, with a mean dwell time of 5.8 years (range 2-12 years), were extracted. After extraction, 6 patients (37.5%) received an SVC stent. Balloon angioplasty was performed before stenting in 5 cases (31.3%). There was 1 major complication (6.3%) due to an SVC tear that was managed surgically with a favorable outcome. Eleven patients underwent reimplantation of a CIED. Over a median follow-up of 5.5 years (interquartile range 2.0-8.5 years), 12 patients (75%) remained free of symptoms. CONCLUSION: Combining TLE with the percutaneous treatment of symptomatic SVC syndrome is a safe and viable treatment strategy.

Transvenous lead extraction during uninterrupted warfarin therapy: Feasibility and outcomes.

BACKGROUND: Uninterrupted anticoagulation is important for patients at high risk for thromboembolism. Bridging with heparin/enoxaparin increases the risk of hematoma and infection. There are no published data on the feasibility of transvenous lead extraction (TLE) during uninterrupted anticoagulation. OBJECTIVE: The purpose of this study was to examine the feasibility and safety of TLE during uninterrupted warfarin therapy with therapeutic international normalized ratio (INR). METHODS: We performed a retrospective study of patients undergoing TLE while receiving uninterrupted warfarin therapy with INR ≥2.0 at a high-volume center. RESULTS: Between March 2011 and December 2016, 1212 patients underwent TLE. Of these patients, 62 underwent TLE during uninterrupted warfarin therapy with therapeutic INR (mean 2.5 ± 0.5; range 2.0-4.5). The cohort was 85% male, mean age 65 years, CHA2DS2-VASc score 3.4 ± 1.6, and left ventricular ejection fraction 41% ± 16%. A total of 114 of 116 leads were completely removed. These include 45 (38.4%) defibrillator leads of average age 7.8 ± 3.7 years, 65 (55.6%) pace-sense leads of average age 10.5 ± 6.6 years, and 6 (5.2%) coronary sinus lead of average age 5.5 ± 3.4 years. There was a 98.4% procedural and clinical success rate. Two patients had procedure-related complications: 1 small pericardial effusion that resolved spontaneously, and 1 femoral vein tear due to extraction of a large mass of a disrupted implantable cardioverter-defibrillator lead requiring vascular repair. CONCLUSION: TLE during uninterrupted warfarin therapy with therapeutic INR may be considered in patients at high risk for thromboembolism if performed by experienced operators at high-volume centers.

Strategies for Transvenous Lead Extraction Procedures.

Transvenous lead extraction (TLE) has undergone an explosive evolution since its inception as a rudimentary skill with limited technology and therapeutic options. Early techniques involved simple manual traction that frequently proved ineffective for chronically implanted leads, and carried a significant risk of myocardial avulsion, tamponade, and death. The morbidity and mortality associated with these early extraction techniques limited their application to use only in life-threatening situations, such as infection and sepsis. The past four decades, however, have witnessed significant advances in lead extraction technology, resulting in more efficacious techniques and tools, providing the skilled extractor with a well-equipped armamentarium. With the development of the discipline, we have witnessed a growth in the community of TLE experts coincident with a marked decline in the incidence of procedure-related morbidity and mortality, with recent registries at high-volume centers reporting high success rates with exceedingly low complication rates. Future developments in lead extraction are likely to focus on new tools that will allow for us to provide comprehensive device management, develop alternative systems for extraction training, and focus on the design of new leads conceived to facilitate future extraction.

Epicardial phrenic nerve displacement during catheter ablation of atrial and ventricular arrhythmias: procedural experience and outcomes.

BACKGROUND: Arrhythmia origin in close proximity to the phrenic nerve (PN) can hinder successful catheter ablation. We describe our approach with epicardial PN displacement in such instances. METHODS AND RESULTS: PN displacement via percutaneous pericardial access was attempted in 13 patients (age 49±16 years, 9 females) with either atrial tachycardia (6 patients) or atrial fibrillation triggered from a superior vena cava focus (1 patient) adjacent to the right PN or epicardial ventricular tachycardia origin adjacent to the left PN (6 patients). An epicardially placed steerable sheath/4 mm-catheter combination (5 patients) or a vascular or an esophageal balloon (8 patients) was ultimately successful. Balloon placement was often difficult requiring manipulation via a steerable sheath. In 2 ventricular tachycardia cases, absence of PN capture was achieved only once the balloon was directly over the ablation catheter. In 3 atrial tachycardia patients, PN displacement was not possible with a balloon; however, a steerable sheath/catheter combination was ultimately successful. PN displacement allowed acute abolishment of all targeted arrhythmias. No PN injury occurred acutely or in follow up. Two patients developed acute complications (pleuro-pericardial fistula 1 and pericardial bleeding 1). Survival free of target arrhythmia was achieved in all atrial tachycardia patients; however, a nontargeted ventricular tachycardia recurred in 1 patient at a median of 13 months' follow up. CONCLUSIONS: Arrhythmias originating in close proximity to the PN can be targeted successfully with PN displacement with an epicardially placed steerable sheath/catheter combination, or balloon, but this strategy can be difficult to implement. Better tools for phrenic nerve protection are desirable.

ICD and CRT use in ischemic heart disease in women.

Although the role of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) in improving outcomes in ischemic cardiomyopathy (ICM) has been described, the data regarding gender-based survival outcomes are limited. There is a higher preponderance of non-ischemic cardiomyopathy (NICM) in women, and most of the ICM literature is derived from sub-study analysis. This review summarizes the current body of literature on prognosis, pathophysiology, and the present clinical practice for device implantation in women with ICM.

Are patients with cardiac implants protected against electromagnetic interference in daily life and occupational environment?

Utilization of cardiac implants such as pacemakers and implantable cardioverter defibrillators is now commonplace among heart disease patients. The ever-increasing technological complexity of these devices is matched by the near omnipresent exposure to electric, magnetic, and electromagnetic fields (EMFs), both in everyday life and the occupational environment. Given that electromagnetic interferences (EMIs) are associated with potential risk in device patients, physicians are increasingly confronted with managing device patients with intermittent EMI and chronic occupational exposure. The current review aims to provide a contemporary overview of cardiovascular implantable electronic devices, their function and susceptibility of non-medical EMFs and provide recommendations for physicians caring for cardiac device patients presenting with EMI.

Virtual reality lead extraction as a method for training new physicians: a pilot study.

BACKGROUND: It is estimated that the demand for transvenous lead extraction (TLE) has reached an annual extraction rate of nearly 24,000 patients worldwide. Despite technologic advances, TLE still has the potential for significant morbidity and mortality. Complication rates with TLE directly parallel operator experience. However, obtaining adequate training during and postfellowship can be difficult. Given the potential for catastrophic complications and the steep learning curve (up to 300 cases) associated with this procedure, we sought to validate a virtual reality (VR) lead extraction simulator as an innovative training and evaluation tool for physicians new to TLE. METHODS: We randomized eight electrophysiology fellows to VR simulator versus conventional training. We compared procedural skill competency between the groups using simulator competency, tactile measurements, markers of proficiency and attitudes, and cognitive abilities battery. RESULTS: Practical skills and simulator complications differed significantly between the VR simulator and conventional training groups. The VR simulator group executed patient preparation and procedure performance better than the conventional group (P < 0.01). All four fellows randomized to conventional training experienced a simulator complication (two superior vena cava [SVC] tears, three right ventricle [RV] avulsions) versus one fellow in the VR simulator group (one SVC tear) (P = 0.02). Tactile measurements revealed a trend toward excess pushing versus pulling forces among the conventionally trained group. The time for lead removal was also significantly higher in the conventional training group (12.46 minutes vs 5.54 minutes, P = 0.02). There was no significant difference in baseline or posttraining cognitive ability. CONCLUSIONS: We contend that the implementation of alternative training tools such as a VR simulation model will improve physician training and allow for an innovative pathway to assess the achievement of competency.

Ventricular tachycardia in cardiac sarcoidosis: characterization of ventricular substrate and outcomes of catheter ablation.

BACKGROUND: Cardiac sarcoid-related ventricular tachycardia (VT) is a rare disorder; the underlying substrate and response to ablation are poorly understood. We sought to examine the ventricular substrate and outcomes of catheter ablation in this population. METHODS AND RESULTS: Of 435 patients with nonischemic cardiomyopathy referred for VT ablation, 21 patients (5%) had cardiac sarcoidosis. Multiple inducible VTs were observed with mechanism consistent with scar-mediated re-entry in all VTs. Voltage maps showed widespread and confluent right ventricular scarring. Left ventricular scarring was patchy with a predilection for the basal septum, anterior wall, and perivalvular regions. Epicardial right ventricular scar overlay and exceeded the region of corresponding endocardial scar. After ≥1 procedures, ablation abolished ≥1 inducible VT in 90% and eliminated VT storm in 78% of patients; however, multiple residual VTs remained inducible. Failure to abolish all inducible VTs was because of septal intramural circuits or extensive right ventricular scarring. Multiple procedure VT-free survival was 37% at 1 year, but VT control was achievable in the majority of patients with fewer antiarrhythmic drugs compared with preablation (2.1±0.8 versus 1.1±0.8; P<0.001). CONCLUSIONS: Patients with cardiac sarcoidosis and VT exhibit ventricular substrate characterized by confluent right ventricular scarring and patchy left ventricular scarring capable of sustaining a large number of re-entrant circuits. Catheter ablation is effective in terminating VT storm and eliminating ≥1 inducible VT in the majority of patients, but recurrences are common. Ablation in conjunction with antiarrhythmic drugs can help palliate VT in this high-risk population.

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.

Multicenter experience with transvenous lead extraction in arrhythmogenic right ventricular cardiomyopathy (ARVC).

BACKGROUND: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is becoming a more commonly diagnosed entity with frequent need for coincident implantable cardioverter defibrillator (ICD) therapy. Given predominant right ventricular disease with thinning of the wall, there is concern regarding the safety of transvenous lead extraction (TLE) in ARVC. METHODS: We performed a retrospective study of consecutive patients with ARVC undergoing TLE of ICD leads at three high-volume centers. Patient and lead characteristics, indications, outcomes, and extraction sheath (ES) use were analyzed. RESULTS: Between 1999 and 2012, more than 2,000 lead extractions were performed at the three centers. Of these, 11 patients underwent 14 extractions meeting inclusion criteria. Mean implant duration was 74.5 months (range 6-140). In 11 patients, a total of 22 leads (16 high-voltage and six pace-sense leads) were extracted in 14 procedures. The cohort was 50% male with a mean age of 45 years (range, 25-56) and mean ejection fraction 55 ± 13%. The majority (64%) of leads were extracted due to lead malfunction, three patients had an ICD lead removed for exit block, and three patients underwent TLE for infectious complications (two local, one systemic). ES assistance with laser or mechanical cutting sheaths was employed in the vast majority of cases (85.7%). All leads were removed completely. There were no major procedural complications. In five cases, lead reimplantation encountered low-amplitude R waves requiring multiple attempted lead positions before final successful implant. CONCLUSIONS: This is the first reported series of TLE in ARVC patients. TLE can be performed safely and effectively in patients with ARVC by experienced operators at high-volume centers with a low complication rate.

Lead electrical parameters may not predict integrity of the Sprint Fidelis ICD lead.

BACKGROUND: The reported failure rate of the Medtronic Sprint Fidelis defibrillator lead continues to increase over time. Clinicians and patients count on the electrical analysis of leads through device interrogation to determine whether a lead is functioning "normally." Most importantly, this analysis is often the basis for decision making around the ongoing use of this lead at the time of generator change. Can clinicians count on this analysis and feel confident that this "advisory" lead is "normal?" OBJECTIVE: To describe the incidence of unexpected lead abnormalities among Sprint Fidelis leads removed without prior evidence of electrical abnormalities. METHODS: We performed a retrospective cohort study of Medtronic Sprint Fidelis (6930, 6931, 6948, 6949) leads extracted at a single high-volume center. Medtronic analyzed all returned leads for abnormalities. The presence and type of lead abnormalities in addition to patient characteristics, indications for extraction, implant duration, and use of extraction sheath assistance are reported. RESULTS: Between September 2005 and January 2011, 209 Sprint Fidelis leads were extracted from 208 patients. The average duration of implant was 38.9 months (range 0.2-67.2). Of the analyzed leads, the majority of the extracted leads (63.1%) were active, normal functioning leads (83.8% prophylactically, 9.1% infection, and 7.1% other indication) while 36.9% had clinical evidence of a fracture. Extraction was achieved with simple traction in 39.5% of the leads; extraction sheath assistance was employed in 94 cases (59.9%), and surgical extraction at the time of transplant occurred in 1 case. Analysis of the 99 functionally "normal" leads removed determined that 20 leads had evidence of fractures (20.2%) not related to extraction. Of the fractured leads, 4 leads (20%) had more than 1 fracture and 1 lead had 3 separate fracture sites. There were 17 pacing conductor (10 proximal and 7 distal conductor) and 6 high-voltage conductor (1 superior vena cava and 5 right ventricle defibrillator conductor) fractures observed. Five additional leads (5.2%) had evidence of explant damage. CONCLUSIONS: Functionally "normal" Fidelis leads demonstrate an alarmingly high rate of "subclinical" fractures. Recommendations regarding prophylactic Sprint Fidelis lead extraction, especially at the time of generator change, may warrant reconsideration. To aid in the design of better leads, all leads should be returned for analysis, regardless of the indication for extraction.

Multicenter experience with transvenous lead extraction of active fixation coronary sinus leads.

BACKGROUND/OBJECTIVE: Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding extraction of chronically implanted active fixation CS leads are limited. METHODS: We performed a retrospective cohort study of patients undergoing active fixation CS lead extraction at six centers. Patient and procedural characteristics, indications for extraction, use of extraction sheath (ES) assistance, and outcomes are reported. RESULTS: Between January 2009 and February 2011, 12 patients underwent transvenous lead extraction (TLE) of Medtronic StarFix® lead (Medtronic Inc., Minneapolis, MN, USA). The cohort was 83% male with mean age 71 ± 14 years. Average implant duration was 14.2 ± 5.7 months (2.3-23.6). All leads but one were removed for infectious indications (67% systemic infection). At the time of explant, the fixation lobes were completely retracted in only one of the 12 cases and ES assistance was required for lead removal in all cases (58% laser, 25% cutting, 25% mechanical, and 25% femoral). The majority of cases required advancement of the sheath into the CS (75.0%) and often into a branch vessel (41.7%). One lead could not be removed transvenously and required surgical lead extraction. There were no major complications. Examination of the leads after extraction frequently revealed significant tissue growth into the fixation lobes. CONCLUSIONS: Although TLE of active fixation CS leads can be a safe procedure in select patients and experienced hands, powered sheaths and aggressive techniques are frequently required for successful removal despite relatively short implant durations. This raises significant concern regarding future TLE of active fixation CS leads with longer implant durations.

Long-term mortality after transvenous lead extraction.

BACKGROUND: The number of cardiovascular implantable electronic devices has increased progressively and has led to an increased need for transvenous lead extraction (TLE). Multiple reports of TLE procedural outcomes exist; however, data regarding postprocedural and long-term mortality are limited. METHODS AND RESULTS: We performed a retrospective study of consecutive patients undergoing TLE at a single, high-volume center. Patient characteristics, indications, and outcomes were analyzed. A multivariable Cox regression model was developed to identify factors associated with mortality. Between January 2000 and December 2010, 985 patients underwent 1043 TLE procedures. The cohort was 68% male, with a mean age of 63 years (range, 15-95 years) and a left ventricular ejection fraction of 40±17%. Indications included systemic infection (18%), pocket infection (32%), lead malfunction (30%), and other (device upgrade, venous occlusion, and advisory leads; 20%). There were no procedure-related deaths. The mean follow-up was 3.7 years (range, 0.1-11.3 years). Kaplan-Meier analysis demonstrated a cumulative mortality of 2.1% at 30 days, 4.2% at 3 months, 8.4% at 1 year, and 46.8% at 10 years. In multivariable analysis, systemic infection (hazard ratio [HR], 3.52; 95% CI, 1.95-6.38; P<0.0001), local infection (HR, 2.70; 95% CI, 1.55-4.67; P=0.0004), device system upgrade (HR, 2.14; 95% CI, 1.07-4.25; P=0.03; indication compared with a reference group of extraction for lead malfunction), diabetes mellitus (HR, 1.71; 95% CI, 1.25-2.35; P=0.0009), increasing age (HR, 1.05; 95% CI, 1.04-1.07; P<0.0001), and serum creatinine (HR, 1.16; 95% CI, 1.01-1.35; P=0.04) were significant correlates of increased mortality risk. CONCLUSIONS: Although TLE procedural mortality is exceedingly low at high-volume centers, postprocedural and long-term mortality remain high in certain patient populations, such as elderly patients and those undergoing TLE for infectious indications and device system upgrade. Information regarding TLE long-term outcomes may help guide cardiovascular implantable electronic device and lead management.