Removal Of Implantable Cardioverter Defibrillator Research Articles

Analysis of 1051 ICD Leads Extractions in Search of Factors Affecting Procedure Difficulty and Complications: Number of Coils, Tip Fixation and Position-Does It Matter?

Background: Implantable cardioverter-defibrillator (ICD) leads are considered a risk factor for major complications (MC) during transvenous lead extraction (TLE). Methods: We analyzed 3878 TLE procedures (including 1051 ICD lead extractions). Results: In patients with ICD lead removal, implant duration was almost half as long (69.69 vs. 114.0 months; p < 0.001), procedure complexity (duration of dilatation of all extracted leads, use of more advanced tools or additional venous access) (15.13% vs. 20.78%; p < 0.001) and MC (0.67% vs. 2.62%; p < 0.001) were significantly lower as compared to patients with pacing lead extraction. The procedural success rate was higher in these patients (98.29% vs. 94.04%; p < 0.001). Extraction of two or more ICD leads or additional superior vena cava (SVC) coil significantly prolonged procedure time, increased procedure complexity and use of auxiliary or advanced tools but did not influence the rate of MC. The type of ICD lead fixation and tip position did not affect TLE complexity, complications and clinical success although passive fixation reduces the likelihood of procedural success (OR = 0.297; p = 0.011). Multivariable regression analysis showed that ICD lead implant duration ≥120 months (OR = 2.956; p < 0.001) and the number of coils in targeted ICD lead(s) (OR = 2.123; p = 0.003) but not passive-fixation ICD leads (1.361; p = 0.149) or single coil ICD leads (OR = 1.540; p = 0.177) were predictors of higher procedure complexity, but had no influence on MC or clinical and procedural success. ICD lead implant duration was of crucial importance, similar to the number of leads. Lead dwell time >10 years is associated with a high level of procedure difficulty and complexity but not with MC and procedure-related deaths. Conclusions: The main factors affecting the transvenous removal of ICD leads are implant duration and the number of targeted ICD leads. Dual coil and passive fixation ICD leads are a bit more difficult to extract whereas fixation mechanism and tip position play a much less dominant role.

682. Implantable Cardioverter-Defibrillator Lead Vegetation with Long-Standing Actinomyces neuii Bacteremia

BackgroundEndocarditis caused by Actinomyces species is uncommon with only 30 cases reported in contemporary literature. MethodsWe present a novel case of cardiovascular implantable electronic device (CIED) endocarditis secondary to infection by Actinomyces neuii – a unique non-branching member of the species that grows in both anaerobic and aerobic media.ResultsOur patient, a 51-year-old female, with a history of implantable cardioverter-defibrillator (ICD) placement 17 years prior for heart failure, presented with six weeks of fevers and rigors. She was referred to the infectious disease clinic for evaluation of pyrexia of unknown origin. Her examination was unremarkable, and the ICD pocket was uninflamed. Her initial labs revealed mildly elevated inflammatory markers and renal insufficiency. Blood cultures were positive for slow-growing non-branching gram-positive rods in both aerobic and anaerobic media. These were identified as Actinomyces neuii by mass spectrometry. Review of outside records showed positive blood cultures with Actinomyces neuii at another facility two weeks prior to our evaluation which were not acted upon and thought to be bacterial contamination. The patient was further evaluated with a transesophageal echocardiogram that demonstrated a 3.3 x 2.2cm mobile vegetation attached to the ICD lead. She subsequently underwent removal of her Saint Jude cardiac resynchronization therapy defibrillator and leads using laser and snaring techniques, but the tail end of the ventricular lead fractured and could not be retrieved. The ICD pocket was also found to be infected. A planned 6-week course of IV ampicillin was interrupted by 2 weeks of ceftriaxone for treatment of an intercurrent lower respiratory tract infection. The patient regained her baseline health and was discharged 2 weeks after ICD removal with a LifeVest. She is to complete 12 months of oral amoxicillin therapy after completion of IV antibiotics in view of retained lead fragment, and long standing Actinomyces bacteremia - consistent with published management strategies. Figure 1. Transesophageal echocardiogram demonstrating size of vegetation. Figure 2. Three-dimensional view demonstrating vegetation on the ICD lead.ConclusionHere we describe the first known case of Actinomyces neuii CIED endocarditis with a large lead vegetation and long-standing bacteremia, presenting as pyrexia of unknown origin.Disclosures All Authors: No reported disclosures

Misdiagnosis of ARVC leading to inappropriate ICD implant and subsequent ICD removal - lessons learned.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited progressive cardiomyopathy characterized by frequent life-threatening arrhythmias. The diagnosis of ARVC is challenging and is on the basis of a set of major and minor criteria as described by the modified Task Force Criteria (TFC). We report our clinical experience in a series of patients who were misdiagnosed with ARVC and subsequently underwent removal of their implantable cardioverter defibrillator (ICD) after a re-evaluation at our center. We studied 12 patients who were misdiagnosed with ARVC and had ICD implantation before our assessment. All patients had a repeat evaluation and were scored according to TFC before ICD removal. Cardiac magnetic resonance imaging (CMR) studies performed at outside institutions during the initial evaluation were reported abnormal and classified as meeting major TFC in ninety percent of patients. The most common abnormality reported was fatty infiltration of the right ventricular (RV) free wall and/or presence of focal intra-myocardial fat in six patients (50%). On re-evaluation, none of these findings fulfilled the TFC for the diagnosis. This study demonstrated that high dependence on misinterpretation of CMR along with a misunderstanding of the TFC evaluation are the main reasons for the misdiagnosis of ARVC. Despite the updated criteria for almost a decade, this study reminds that the diagnosis of ARVC is complex and hence careful TFC evaluation and consideration of multiple cardiac test results should be the focused approach for clinicians when confronted with suspected ARVC patients.

Implantable cardioverter-defibrillator therapy in Australia, 2002-2015.

To quantify the number of implantable cardioverter-defibrillator (ICD) procedures in Australia by year, patient age and sex, and to estimate age group-specific population rates and the associated costs. Design, setting: Retrospective observational study; analysis of Australian National Hospital Morbidity Database hospital procedures data. Patients with an ICD insertion, replacement, adjustment, or removal procedure code, July 2002 - June 2015. Number of ICD procedures by procedure year, patient age (0-34, 35-69, 70 years or more) and sex; age group-specific population procedure rates; number of procedures associated with complications. The number of ICD procedures increased from 1844 in 2002-03 to 6504 in 2014-15; more than 75% of procedures were in men. In 2014-15, the ICD insertion rate for people aged 70 years or more was 78.1 per 100 000 population, 22 per 100 000 for those aged 35-69 years, and 1.40 per 100 000 people under 35. The reported complication rate decreased from 45% in 2002-03 to 19% in 2014-15, partly because of a change in the coding of complications. The number of removals corresponded to at least 4% of the number of insertions each year. The aggregate cost of hospitalisations with an ICD procedure during 2011-14 was $445 644 566. ICD procedures are becoming more frequent in Australia, particularly in people aged 70 or more. Patterns of care associated with ICD therapy, particularly patient- and hospital-related factors associated with adverse events, should be investigated to better understand and improve patient outcomes.

The wearable cardioverter defibrillator as a bridge to reimplantation in patients with ICD or CRT-D-related infections

BackgroundThe approach to treat device infection in patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) is a challenging procedure. Optimal treatment is complete extraction of the infected device. To protect these patients from sudden cardiac arrest while waiting for reimplantation and to avoid recurrent infection, a wearable cardioverter defibrillator (WCD) seems to be a valuable solution.Therefore, we investigated the management and outcome of patients with ICD or CRT-D infections using the WCD as a bridge to re-implantation after lead extraction procedures.MethodsWe conducted a retrospective study on consecutive patients who underwent ICD or CRT-D removal due to device-related local or systemic infections. All patients were prescribed a WCD at our center between 01/2012 and 10/2015. All patients returned to our outpatient clinic for regular ICD or CRT-D monitoring initially 1 and 3 months after reimplantation followed by 6-months intervals.ResultsTwenty-one patients (mean age 65.0 ± 8.0 years, male 76.2%) were included in the study. Complete lead extraction was achieved in all patients. While waiting for reimplantation one patient experienced a symptomatic episode of sustained ventricular tachycardia. This episode was converted successfully into sinus rhythm by a single 150 J shock.Mean follow-up time 392 ± 206 days, showing survival rate of 100% and freedom from reinfection in all patients.ConclusionThe WCD seems to be a valuable bridging option for patients with ICD or CRT-D infections, showing no recurrent device infection.

Benefit of the Wearable Cardioverter-Defibrillator in Protecting Patients AfterImplantable-Cardioverter Defibrillator Explant: Results From the National Registry.

This study reports on the time course of reimplantation and benefits of the wearable cardioverter-defibrillator (WCD) in patients post implantable cardioverter-defibrillator (ICD) explantation. The WCD is used to treat patients at high risk for ventricular tachycardia (VT) and ventricular fibrillation (VF), including patients with ICD-related infections who undergo device removal and cannot be immediatelyreimplanted. This retrospective study included consecutive patients from 2002 to 2014 who underwent ICD removal because of device-related infection and were prescribed a WCD. WCD-stored electrocardiograms were reviewed. Event outcome was assessed through either the manufacturer WCD registry or the Social Security death index search. A total of 8,058 patients (mean age 62 ± 14 years, 75% male) were included in the analysis. Median time to reimplantation of an ICD was 50 days (interquartile range: 24 to 83 days). While wearing the WCD, 334 patients (4%) experienced 406 VT/VF events, of which 348 events were treated. Shocks were averted in 54 events by conscious patients. The overall 24-h survival, both treated and nontreated, was 93% (312 of 334). VT/VF occurrence was the highest in the initial weeks after ICD removal (0.9%, 0.7%, and 0.7% per week for weeks 1, 2, and 3, respectively). The12-month cumulative event rate was 10%. For all patients, the 30-day post-event survival was 81%. An ICD was reimplanted in 80% of patients. The risk of VT/VF reaches 4% during the first 2 months and 10% at 1 year after ICD removal. WCD demonstrated a high efficacy for protecting patients from VT/VF. Clinicians may use the WCD as an ICD alternative when reimplantation is medically delayed.

Laser lead extraction allows for safe and effective removal of single- and dual-coil implantable cardioverter defibrillator leads: A single-centre experience over 12 years.

Lead extraction in patients with multiple or old leads of an implantable cardioverter defibrillator (ICD) is challenging. As adhesions are common at the side of the shock coils, we investigated success and procedural complication rates of laser lead extraction procedures in single- and dual-coil leads. Between January 2001 and June 2013, 41 single- and 145 dual-coil ICD leads were extracted from 171 patients using laser sheaths. Procedural data, success rates and complications were collected into a database and retrospectively analysed. The mean patient age was 58.2 ± 16.1 years. The mean time from initial lead implantation to extraction was 50.3 ± 18.4 and 45.8 ± 14.5 months in the single- and dual-coil group, respectively (P = 0.1). In the single-coil group, complete procedural success was achieved in 36 of 37 (97.3%) cases, and clinical success in all cases (100.0%). In the dual-coil group, complete procedural success was seen in 131 out of 134 (97.8%) patients, and clinical success in 132 of 134 cases (98.5%). The transvenous extraction failed in 2 cases (1.5%). The overall complication rate was 2.7% in the single-coil group and 3.7% in the dual-coil group, respectively (P = 1.0). No deaths occurred during the 30-day follow-up. The mean laser treatment time was 1.8 ± 1.5 min for the single-coil group and 2.5 ± 1.2 min for dual-coil group (P = 0.002). Laser lead extraction allows for safe and effective removal of ICD leads. Compared with single-coil leads, the extraction of dual-coil leads is associated with longer laser treatment times but without statistically significant differences in complications and procedural success rates.

High‐Risk Lead Removal by Planned Sequential Transvenous Laser Extraction and Minimally Invasive Right Thoracotomy

Transvenous pacemaker or implantable cardioverter defibrillator (ICD) lead extraction via mechanical or excimer laser sheath is typically safe and effective. Longer duration from implant, presence of large vegetations or thrombi, fractured leads, and prior failed extraction are risk factors predicting higher complication rates or incomplete or failed lead removal. Techniques developed for minimally invasive valve surgery were used in conjunction with laser extraction to refine a "hybrid" technique for lead extraction. We assessed the outcomes of high-risk lead extraction using this hybrid lead extraction technique. Retrospective assessment of clinical parameters and procedural outcomes in patients undergoing planned hybrid lead extraction from February 2008 to September 2012 was performed. We report 8 cases of hybrid lead extraction performed at our institution. We extracted 21 leads with average lead age of 13.8 years since implant. All leads were removed with complete clinical and radiographic success. There were no intraprocedure complications. One patient died of continued sepsis and 1 other had symptoms consistent with pulmonary embolism. Hybrid lead extraction using this technique is a safe and effective approach for removal of high-risk chronic pacemaker or ICD leads. This method extends the range of approachable leads resulting in complete removal without median sternotomy. Hybrid lead extraction can be scheduled electively facilitating complete lead removal with a low complication rate and short postoperative recovery time, mitigating the risks inherent in midline sternotomy or emergent cardiac surgical rescue.

Protection from outpatient sudden cardiac death following ICD removal using a wearable cardioverter defibrillator.

An implantable cardioverter defibrillator (ICD) is effective in preventing sudden cardiac death (SCD). Once an ICD is removed and reimplantation is not feasible, a wearable cardioverter defibrillator (WCD) may be an alternative option. We determined the effectiveness of WCD for SCD prevention in patients who were discharged after ICD removal. A retrospective study was conducted on all WCD (LifeVest, ZOLL, Pittsburgh, PA, USA) patients who underwent ICD removal due to cardiac device infections (CDIs) at two referral centers between January 1, 2005 and December 31, 2009. Clinical characteristics, device information, and WCD data were analyzed. Sudden cardiac arrest was defined as all sustained ventricular tachycardia (VT) and ventricular fibrillation occurring within a single 24-hour period. Ninety-seven patients (mean age 62.8 ± 13.3, male 80.4%) were included in the study. The median duration of antibiotic use was 14.7 days (interquartile range [IQR] 10-30). The median daily WCD use was 20 hours/day and the median length of use was 21 days (IQR 5-47). A total of three patients were shocked by WCD. Two patients had four episodes of sustained VT, successfully terminated by the WCD. A third patient experienced two inappropriate treatments due to oversensitivity of the signal artifact. Three patients experienced sudden death outside the hospital while not wearing the device. Five patients died while hospitalized. WCD can prevent SCD, until ICD reimplantation is feasible in patients who underwent device removals for CDI. However, patient compliance is essential for the effective use of this device.

Abstract 245: Economic Evaluation of the Wearable Cardioverter-Defibrillator in Patients After ICD Explantation

Introduction Device infection and lead failure are severe complications in implantable cardioverter defibrillator (ICD) recipients. The standard of care includes aggressive antibiotic therapy and in many cases ICD system removal, leaving patients unprotected from sudden cardiac death (SCD). Studies have demonstrated that the wearable cardioverter defibrillator (WCD) is effective in bridging patients while infections are resolved and they can have their devices re-implanted. Hypothesis We sought to evaluate whether WCD is cost-effective in ICD explantation patients. Methods We included all WCD patients whose medical orders indicated an ICD removal. Patients' compliance, shock events, outcomes, and end of use reasons were retrieved from the manufacturer database (ZOLL). Direct and indirect costs other than WCD itself, probabilities of ventricular arrhythmia and mortality were estimated from published articles. The WCD survival rate was calculated as number of saves (remain at home or conscious arrival at the ER) out of the total true shock events. Patients who finished a WCD therapy course were most often re-implanted, with some relying on standard medical therapy only. We used non-WCD patients who utilized the regular emergency medical service (EMS) as the baseline; and computed the incremental cost-effectiveness ratio (ICER) as the difference in costs divided by the difference in lives saved and life-year gained, respectively, within 5 years. Sensitivity analyses were performed to assess how the two ICERs responded as the values of variables changed. All monetary cost was converted to 2010 dollars at a 3% discount rate. Results A total of 3,021 patients used a WCD after an ICD explantation. The mean length of use was 45.4±58.3 days, with an average daily use of 20.35±5.8 hours (85% of the day, median=21 hours). Among those who had ended use, 56.1% got re-implanted. We estimated the first-month mortality was 2.5 times higher than the subsequent months. The calculated ICERs for WCD were $105,869 per life saved and $27,493 per life-year gained. Sensitivity analysis revealed that the ratios were not sensitive to the percentage of re-implantation. Conclusions The use of WCD is highly cost-effective in protecting ICD explantation patients against SCD.

Pacemaker and ICD lead extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial

The purpose of this prospective randomized study was to evaluate the safety and efficacy of transvenous pacemaker and implantable cardioverter-defibrillator (ICD) lead extraction with an electrosurgical dissection sheath (EDS) system in a single-centre experience. Methods Over 10 years, 462 patients have undergone transvenous lead extraction in our institution. From these, 120 consecutive patients (with 161 leads) were randomized to either radiofrequency (RF) current supported extraction or standard countertraction lead removal (60 patients in each arm, 96 men and 24 women). The mean age of randomized patients was 62.7 +/- 9.6 years. In 16 patients, we explanted 17 ICD leads. The average time from the date of implantation to the extraction procedure was 73.4 +/- 15.7 months. The most common reason for lead extraction was infection (95.6%). Results The complete extraction of 78 leads (93%) was achieved in the RF group and 56 leads (73%) with the standard transvenous lead extraction system by counter-traction (P < 0.01). Among these leads, we successfully removed nine of 10 ICD leads (90%) in the RF group and only four of seven ICD leads (57%) in the standard group. We also observed a significant reduction in the time taken for the successful removal of pacemaker and ICD leads using the RF system (9.6 +/- 6.2 min versus 21 +/- 9 min, P < 0.01). Partial success was achieved in six patients with the RF system and in 11 with standard sheaths. In those cases where we failed to remove the lead from the body we sent all but one patient to cardiac surgery. Serious complications were associated with the standard system in two patients, both of whom developed septic pulmonary embolization. Serious bleeding occurred in three patients, one with standard and two with the EDS lead extraction system. The EDS extraction system is significantly more effective and quicker. However, the standard counter-traction method is still an effective alternative when used in a highly experienced centre.

Effectiveness of Excimer Laser‐Assisted Pacing and ICD Lead Extraction in Children and Young Adults

High capture thresholds, decreased electrical sensing, and lead fractures continue to be a problem in children undergoing transvenous pacing. The clinician must therefore decide at the time of pacing system revision to either abandon chronically implanted transvenous pacing leads or extract them. We report our experience using an excimer laser-assisted (LA) strategy for removing chronically implanted pacing (36) and implantable cardioverter/defibrillator (ICD) (7) leads in children and young adults. The study population consisted of 25 patients, in whom 29 procedures were performed. The patients ranged in age from 8.4 to 39.9 years, median age was 13.9 years, at the time of the extraction procedure. In all procedures, a Spectranectics locking stylet and excimer laser sheath were used to assist in lead extraction. Lead removal was complete for 39 (91%) leads, and partial for four leads. In two patients, the pacing lead tip was retained and in two, the ring electrode from a bipolar pacing lead was left in situ. All ICD leads were removed completely. Two major complications occurred--cardiac perforation and tamponade (1), and thrombosis of the left subclavian/innominate vein (1). LA extraction facilitated the implantation of new pacing or ICD leads in three patients with obstructed venous access. Removal of pacing and ICD leads using an excimer LA technique was highly successful. Lead removal was complete in 91%. The most common indication for lead removal in our study was lead fracture. Complications were few, but may be significant.

Feasibility, safety, and determinants of extraction time of percutaneous extraction of endocardial implantable cardioverter defibrillator leads by intravascular countertraction method

Previous studies of the removal of implantable cardioverter defibrillator (ICD) leads have been restricted to case reports or small series. In this report, we describe our experience in ICD lead extraction by intravascular countertraction method using Cook’s extraction kit. A total of 47 high-voltage (HV) leads, 3 rate sensing (S) leads, and 2 subcutaneous arrays were removed from 42 patients (33 men, 9 women; mean age 59 years [range 14 to 81]). One HV superior vena cava (SVC) lead and 11 HV right ventricular (RV) leads were explanted by manual traction only and defined in the “lead removal” category. One S lead was removed using a femoral venous approach. The remaining 37 leads were explanted by SVC approach using extraction sheaths and defined in the “lead extraction” category. Twenty leads were extracted for “infectious” (group A) and 17 leads for “noninfectious” (group B) etiologies for which extraction times of 27.0 ± 18.0 and 27.0 ± 15.0 minutes (mean ± SD), respectively, were not different. Although extraction time, 34.0 ± 11.0 minutes, for leads implanted for >48 months was longer than 23.0 ± 16.0, 28.0 ± 18.0, and 24.0 ± 14.0 minutes, for leads with implant durations of 12, 24, and 48 months, respectively, such differences were not statistically significant. The extraction time, however, was directly related to the degree of fibrosis around the lead, 39.0 ± 15.0 minutes for leads with severe fibrosis compared with 13.0 ± 6.0 minutes for the leads with mild fibrosis (p <0.001). Patient’s age, sex, or history of coronary artery bypass graft surgery did not significantly affect extraction time. All except the initial 2 lead extractions were performed in the electrophysiology laboratory. No mortality or serious complications associated with the procedure using these methods were observed.