Mid-term performance of His bundle pacing and usefulness of backup leads.

Ventricular backup leads may be considered in selected patients with His bundle pacing (HBP), but it remains unknown to what extent this is useful. A total of 184 HBP patients were studied. At last follow-up, 147 (79.9%) patients retained His bundle capture at programmed output. His bundle pacing lead revision was performed in 5/36 (13.9%) patients without a backup lead and in 3/148 (2.0%) patients with a backup lead (P = 0.008). One patient without a backup lead had syncope due to atrial oversensing. Thus, implantation of ventricular backup leads may avoid lead revision and adverse events in selected HBP patients.

Long-term performance of single-connector (DF4) implantable defibrillator leads.

AIMS: Single-connector (DF4) defibrillator leads have become the predominantly implanted transvenous implantable cardioverter-defibrillator lead. However, data on their long-term performance are derived predominantly from manufacturer product performance reports. METHODS AND RESULTS: We reviewed medical records in 5289 patients with DF4 leads between 2011 and 2023 to determine the frequency of lead-related abnormalities. We defined malfunction as any single or combination of electrical abnormalities requiring revision including a sudden increase (≥2×) in stimulation threshold, a discrete jump in high-voltage impedance, or sensing of non-physiologic intervals or noise. We documented time to failure, predictors of failure, and management strategies. Mean follow-up after implant was 4.15 ± 3.6 years (median = 3.63), with 37% of leads followed for >5 years. A total of 80 (1.5%) leads demonstrated electrical abnormalities requiring revision with an average time to failure of 4 ± 2.8 years (median = 3.5). Of the leads that malfunctioned, 62/80 (78%) were extracted and replaced with a new lead and in the other 18 cases, malfunctioned DF4 leads were abandoned, and a new lead implanted. In multivariable models, younger age at implant (OR 1.03 per year; P < 0.001) and the presence of Abbott/St. Jude leads increased the risk of malfunction. CONCLUSION: DF4 defibrillator leads demonstrate excellent longevity with >98.3% of leads followed for at least 5 years still functioning normally. Younger age at implant and lead manufacturer are associated with an increased risk of DF4 lead malfunction. The differences in lead survival between manufacturers require further investigation.

Vagus nerve stimulator revision in pediatric epilepsy patients: a technical note and case series.

INTRODUCTION: Vagus nerve stimulation (VNS) is an adjunctive treatment in children with intractable epilepsy. When lead replacement becomes necessary, the old leads are often truncated and retained and new leads are implanted at a newly exposed segment of the nerve. Direct lead removal and replacement are infrequently described, with outcomes poorly characterized. We aimed to describe our experience with feasibility of VNS lead removal and replacement in pediatric patients. METHODS: Retrospective review examined 14 patients, at a single, tertiary-care, children's hospital, who underwent surgery to replace VNS leads, with complete removal of the existing lead from the vagus nerve and placement of a new lead on the same segment of the vagus nerve, via blunt and sharp dissection without use of electrocautery. Preoperative characteristics, stimulation parameters, and outcomes were collected. RESULTS: Mean age at initial VNS placement was 7.6 years (SD 3.5, range 4.5-13.4). Most common etiologies of epilepsy were genetic (5, 36%) and cryptogenic (4, 29%). Lead replacement was performed at a mean of 6.0 years (SD 3.8, range 2.1-11.7) following initial VNS placement. Reasons for revision included VNS lead breakage or malfunction. There were no perioperative complications, including surgical site infection, voice changes, dysphagia, or new deficits postoperatively. Stimulation parameters after replacement surgery at last follow-up were similar compared to preoperatively, with final stimulation parameters ranging from 0.25 mA higher to 1.5 mA lower to maintain baseline seizure control. The mean length of follow-up was 7.9 years (SD 3.5, range 3.1-13.7). CONCLUSION: Removal and replacement of VNS leads are feasible and can be safely performed in children. Further characterization of surgical technique, associated risk, impact on stimulation parameters, and long-term outcomes are needed to inform best practices in VNS revision.

A single-center experience with early adoption of physiologic pacing approaches.

BACKGROUND: Increasing interest in physiological pacing has been countered with challenges such as accurate lead deployment and increasing pacing thresholds with His-bundle pacing (HBP). More recently, left bundle branch area pacing (LBBAP) has emerged as an alternative approach to physiologic pacing. OBJECTIVE: To compare procedural outcomes and pacing parameters at follow-up during initial adoption of HBP and LBBAP at a single center. METHODS: Retrospective review, from September 2016 to January 2020, identified the first 50 patients each who underwent successful HBP or LBBAP. Pacing parameters were then assessed at first follow-up after implantation and after approximately 1 year, evaluating for acceptable pacing parameters defined as sensing R-wave amplitude >5 mV, threshold <2.5 V @ 0.5 ms, and impedance between 400 and 1200 Ω. RESULTS: The HBP group was younger with lower ejection fraction compared to LBBAP (73.2 ± 15.3 vs. 78.2 ± 9.2 years, p = .047; 51.0 ± 15.9% vs. 57.0 ± 13.1%, p = .044). Post-procedural QRS widths were similarly narrow (119.8 ± 21.2 vs. 116.7 ± 15.2 ms; p = .443) in both groups. Significantly fewer patients with HBP met the outcome for acceptable pacing parameters at initial follow-up (56.0% vs. 96.4%, p = .001) and most recent follow-up (60.7% vs. 94.9%, p ≤ .001; at 399 ± 259 vs. 228 ± 124 days, p ≤ .001). More HBP patients required lead revision due to early battery depletion or concern for pacing failure (0% vs. 13.3%, at a mean of 664 days). CONCLUSION: During initial adoption, HBP is associated with a significantly higher frequency of unacceptable pacing parameters, energy consumption, and lead revisions compared with LBBAP.

Long-Term Implications of Pacemaker Insertion in Younger Adults: A Single Centre Experience.

BACKGROUND: The long-term implications of pacemaker insertion in younger adults are poorly described in the literature. METHODS: We performed a retrospective analysis of consecutive younger adult patients (18-50 yrs) undergoing pacemaker implantation at a quaternary hospital between 1986-2020. Defibrillators and cardiac resynchronisation therapy devices were excluded. All clinical records, pacemaker checks and echocardiograms were reviewed. RESULTS: Eighty-one (81) patients (median age 41.0 yrs IQR=35-47.0, 53% male) underwent pacemaker implantation. Indications were complete heart block (41%), sinus node dysfunction (33%), high grade AV block (11%) and tachycardia-bradycardia syndrome (7%). During a median 7.9 (IQR=1.1-14.9) years follow-up, nine patients (11%) developed 13 late device-related complications (generator or lead malfunction requiring reoperation [n=11], device infection [n=1] and pocket revision [n=1]). Five (5) of these patients were <40 years old at time of pacemaker insertion. At long-term follow-up, a further nine patients (11%) experienced pacemaker-related morbidity from inadequate lead performance managed with device reprogramming. Sustained ventricular tachycardia was detected in two patients (2%). Deterioration in ventricular function (LVEF decline >10%) was observed in 14 patients (17%) and seven of these patients required subsequent biventricular upgrade. Furthermore, four patients (5%) developed new tricuspid regurgitation (>moderate-severe). Of 69 patients with available long-term pacing data, minimal pacemaker utilisation (pacing <5% at all checks) was observed in 13 (19%) patients. CONCLUSIONS: Pacemaker insertion in younger adults has significant long-term implications. Clinicians should carefully consider pacemaker insertion in this cohort given risk of device-related complications, potential for device under-utilisation and issues related to lead longevity. In addition, patients require close follow-up for development of structural abnormalities and arrhythmias.

A case report of lead dysfunction presenting as high ventricular premature complex burden.

Pacemaker-troubleshooting is an important step in the evaluation of a patient with syncope post-pacemaker-implantation. The basic functions of sensing, pacing and impedance may remain spuriously normal in the case of lead-microfracture or insulation break. We report a case in which the lead dysfunction was diagnosed based on multiple episodes of premature ventricular beats.

His bundle pacing capture threshold stability during long-term follow-up and correlation with lead slack.

AIMS: His bundle pacing (HBP) is the most physiologic form of pacing. Long-term HBP capture threshold stability and its relation to lead characteristics at the time of implantation have not been adequately described. The aim of this study was to characterize HB capture threshold in follow-up and to identify potential lead characteristics predictive of lead capture instability. METHODS AND RESULTS: Consecutive patients with successful HBP for bradycardia indications were identified from the Geisinger HBP registry. His bundle capture thresholds, baseline comorbidities, and radiographic lead slack characteristics were analysed. An increase in HB capture threshold ≥1 V above implant values at any time during follow-up was tracked. Forty-four of the 294 studied (15%) experienced HB capture threshold increase by ≥ 1 V. Threshold increase was seen early (41% by 8 weeks, 66% by 1 year). Eighteen (6%) patients required lead revision in follow-up. Abnormal slack shape was associated with a trend toward capture threshold increase [hazard ratio (HR) 2.07; 95% confidence interval (CI) 0.9-4.6; P = 0.08]. Non-perpendicular angle of lead insertion on radiography was associated with the capture threshold increase (HR 2.81, 95% CI 1.4-5.8; P < 0.01). CONCLUSION: His bundle capture threshold remains stable in the majority (85%) of patients. Implant characteristics may predict the threshold rise. Further evaluation of the aetiology of threshold increase and design changes in lead and delivery systems may lead to chronically stable capture thresholds.

Percutaneous management of lead-related cardiac perforation with limited use of computed tomography and cardiac surgery.

BACKGROUND: Cardiac implantable electronic device (CIED)-related perforation is uncommon but potentially lethal. Management typically includes the use of computed tomography (CT) scanning and often involves cardiac surgery. METHODS: Patients presenting to a single referral centre with CIED-related cardiac perforation between 2013 and 2019 were identified. Demographics, diagnostic modalities, the method of lead revision, and 30-day complications were examined. RESULTS: A total of 46 cases were identified; median time from implantation to diagnosis was 14 days (interquartile range = 4-50). Most were females (29/46, 63%), 9/46 (20%) had cancer, 18 patients (39%) used oral anticoagulants, and no patients had prior cardiac surgery. Active fixation was involved in 98% of cases; 9% involved an implantable cardioverter defibrillator lead. Thirty-seven leads perforated the right ventricle (apex: 24) and 9 punctured the right atrium (lateral wall: 5). Abnormal electrical parameters were noted in 95% of interrogated cases. Perforation was visualized in 41% and 6% of cases with chest X-ray (CXR) and transthoracic echocardiography, respectively. CXR revealed a perforation, gross lead displacement, or left-sided pleural effusion in 74% of cases. Pericardial effusion occurred in 26 patients (57%) of whom 11 (24%) developed tamponade, successfully drained percutaneously. Pre-extraction CT scan was performed in 19 patients but was essential in four cases. Transvenous lead revision (TLR) was successfully performed in all cases with original leads repositioned in six patients, without recourse to surgery. Thirty-day mortality and complications were low (0% and 26%, respectively). CONCLUSION: CT scanning provides incremental diagnostic value in a minority of CIED-related perforations. TLR is a safe and effective strategy.

Implantable cardioverter-defibrillator lead revision following left ventricular assist device implantation.

INTRODUCTION: Lead dysfunction can lead to serious consequences including failure to treat ventricular tachycardia or fibrillation (VT/VF). The incidence and mechanisms of lead dysfunction following left ventricular assist device (LVAD) implantation are not well-described. We sought to determine the incidence, mechanisms, timing, and complications of right ventricular lead dysfunction requiring revision following LVAD implantation. METHODS: Retrospective observational chart review of all LVAD recipients with pre-existing implantable cardioverter-defibrillator (ICD) from 2009 to 2018 was performed including device interrogation reports, laboratory and imaging data, procedural reports, and clinical outcomes. RESULTS: Among 583 patients with an ICD in situ undergoing LVAD implant, the median (interquartile range) age was 62.5 (15.7) years, 21% were female, and the types of LVADs included HeartWare HVAD (26%), HeartMate II (52%), and HeartMate III (22%). Right ventricular lead revision was performed in 38 patients (6.5%) at a median (25th, 75th) of 16.4 (3.6, 29.2) months following LVAD. Mechanisms of lead dysfunction included macrodislodgement (n = 4), surgical lead injury (n = 4), recall (n = 3), insulation failure (n = 8) or conductor fracture (n = 7), and alterations in the lead-myocardial interface (n = 12). Undersensing requiring revision occurred in 22 (58%) cases. Clinical sequelae of undersensing included failure to detect VT/VF (n = 4) and pacing-induced torsade de pointes (n = 1). Oversensing occurred in 12 (32%) and sequelae included inappropriate antitachycardia pacing ([ATP], n = 8), inappropriate ICD shock (n = 6), and ATP-induced VT (n = 1). CONCLUSION: The incidence of right ventricular lead dysfunction following LVAD implantation is significant and has important clinical sequelae. Physicians should remain vigilant for lead dysfunction after LVAD surgery and test lead function before discharge.

Clinical efficacy of lead revisions during the test phase in sacral neuromodulation for fecal incontinence.

BACKGROUND: Success rates of up to 80% have been reported for the SNM screening period in the treatment of fecal incontinence (FI). Some patients who have an unsuccessful index implantation are successfully treated with SNM after a lead revision. There is a lack of studies comparing the outcomes of successful index implantations and successful lead revision. Therefore, the results of index implantations were compared with lead revisions in a single-center cohort. METHODS: Patients treated with SNM for FI between 2008 and 2016 were retrospectively reviewed. Patients with a successful index implantation were compared with patients who underwent lead revision after SNM screening. Primary outcome was a decrease in episodes of fecal incontinence of ≥ 50% documented by a 3-week bowel habit diary. RESULTS: Two hundred sixty-one patients (232 index group, 29 revision group) were eligible for SNM. Two hundred thirty-one patients (208 index group, 23 revision group) received permanent SNM. Follow-up was 68.8 months for the index group and 62.2 months for the revision group. The number of episodes of FI decreased from 20.6 (SD 19.3) to 3.4 (SD 4.2) in the index group and from 12.6 (SD 5.8) to 2.0 (SD 2.3) in the revision group. This effect was maintained up to 5 and 2 years in the index and revision group, respectively. Adverse events such as loss of efficacy which required surgical intervention did not differ between the two groups. CONCLUSION: Lead revision during the test phase is a valid option in patients with FI treated by SNM who suffer from loss of efficacy of the index electrode.

Outcomes of lead revision for myocardial perforation after cardiac implantable electronic device placement.

INTRODUCTION: Cardiac perforation is an infrequent but potentially life-threatening complication associated with placement of a cardiac implantable electronic device (CIED). The objective of this study was to determine the outcomes of percutaneous lead revision in patients who had lead perforation of the myocardium after CIED placement. METHODS AND RESULTS: We reviewed records of 1,458 patients who underwent CIED lead extraction or repositioning. Of these, 31 (2.1%) had the procedure performed for lead perforation as a complication of CIED placement. Demographic, clinical, and follow-up characteristics of the patients were analyzed. Mean (SD) patient age was 65 (23) years. Cardiac perforation was detected within 24 hours after implantation in 9 patients, within 1 month in 17, and greater than 1 month in 5. Pericardiocentesis was performed with a pigtail drainage catheter in place before the lead revision in 17 patients (55%) who had pericardial effusion, with or without hemodynamic compromise. All culprit leads were successfully managed with percutaneous lead removal (n = 3 [10%]), new lead placement (n = 12 [38%]), or lead repositioning (n = 16 [52%]). Of the 17 patients with pericardiocentesis before the reoperation, none had tamponade develop; in contrast, 3 of the remaining 14 patients had tamponade develop and required urgent pericardiocentesis. All patients survived without requiring open chest surgery. CONCLUSION: Percutaneous removal or repositioning of the perforating lead is feasible and appears effective. Placement of a prophylactic pericardial drain catheter may reduce the incidence of urgent pericardiocentesis during or after a procedure.

Lead revision surgery for vagus nerve stimulation in epilepsy: outcomes and efficacy.

We present, to our knowledge, the first published analysis of vagus nerve stimulation (VNS) lead revisions to incorporate quality of life, clinical response, and antiepileptic drug (AED) burden in postrevision clinical outcomes. Ten patients were followed and had no postoperative complications. Seven patients had improvement in quality of life, and three experienced no change. Eight patients noted a restoration of clinical response comparable with initial VNS implantation. Seven patients reported 30-60% improvement in seizure reduction, two experienced >60%, and one noted <30%. Six patients had no change in AED burden. Vagus nerve stimulation lead revision should be considered a safe option for patients with VNS lead failure and medically intractable epilepsy.

Long-Term Outcomes in Patients With Relatively High His-Bundle Capture Threshold After Permanent His-Bundle Pacing　- A Multicenter Clinical Study.

Background: Outcomes in patients with relatively high His-bundle (HB) capture thresholds at implantation are unknown. This study aimed to compare changes in the HB capture threshold and prognosis between patients with a relatively high threshold and those with a low threshold. Methods and Results: Forty-nine patients who underwent permanent HB pacing (HBP) were divided into two groups: low (<1.25 V at 1.0 ms; n=35) and high (1.25-2.49 V; n=14) baseline HB capture threshold groups. The HB capture threshold was evaluated at implantation, and after 1 week, 1, 3, and 6 months, and every 6 months thereafter. HB capture threshold rise was defined as threshold rise ≥1.0 V at 1.0 ms compared with implantation measures. We compared outcomes between the groups. During a mean follow-up period of 34.6 months, the high-threshold group showed a trend toward a higher incidence of HB capture threshold of ≥2.5 V (50% vs. 14%; P=0.023), HBP abandonment (29% vs. 8.6%; P=0.091), lead revision (21% vs. 2.9%; P=0.065), and clinical events (all-cause death, heart failure hospitalization, and new-onset or progression of atrial fibrillation; 50% vs. 23%; P=0.089) than the low-threshold group. A baseline HB capture threshold of ≥1.25V was an independent predictor of clinical events. Conclusions: A relatively high HB capture threshold is associated with increased risk of HBP abandonment, lead revision, and poor clinical outcomes.

Unusual presentation of asymptomatic subacute lead-related ventricular perforation beyond the pericardium without pericardial effusion: a case report.

The clinical manifestations of subacute pacemaker lead-related cardiac perforations are highly variable. Patients with subacute perforations can present with a variety of symptoms, whereas those with acute perforations usually present with cardiac tamponade that necessitates emergent pericardiocentesis. A 32-year-old woman underwent pacemaker implantation for sick sinus syndrome. An active-fixation atrial lead was fixed to the right atrial appendage, and a ventricular lead was fixed to the right ventricle (RV) apex, with acceptable parameters. Two weeks postoperative, the patient visited the clinic for routine examination of the pacemaker parameters. Chest X-ray showed migration of the RV lead beyond the cardiac silhouette. Echocardiography revealed no evidence of pericardial effusion or tamponade. Computed tomography revealed that the RV lead was positioned beyond the RV and pericardium and into the anterior chest wall. Procedural lead revision was performed with cardiothoracic surgery backup. The lead was retracted after loosening the active-fixation screw and inserting the stylet. The lead was placed in the RV septum with active fixation. The procedure was completed without complications, and the patient was discharged after 3 days. Subacute lead perforations can present with various symptoms, and some patients may be asymptomatic without pericardial effusion. Altered lead parameters frequently provide the first indication for the diagnosis of cardiac perforation. Transvenous lead revision with surgical backup is an alternative to surgical extraction.

[Lead extraction in cardiac implantable electronic devices]. / Sondenextraktionen bei implantierbaren kardialen Devices.

Lead extraction due to infection or lead dysfunction has become more important in recent years. Patients with high risk of severe and life-threatening complications should only undergo surgery in experienced centers where appropriate personnel and equipment are available. In this review, different techniques and methods to safely and successfully perform transvenous lead extraction are summarized.

Prevalence, management, and prediction of venous access site occlusion in patients undergoing lead revision surgery.

BACKGROUND: Implantable electronic cardiac devices (CIED) have emerged as an essential component in the treatment of cardiac arrhythmias and heart failure. Due to increased life expectancy, expanding indications and limited technical survival, an increasing number of revision procedures can be anticipated. Venous access site occlusion (VASO) is the main obstacle during revision surgery. In this retrospective study we evaluated the prevalence, predictive parameters and operative management of venous access site occlusion. METHODS AND RESULTS: Between 01/2016 and 12/2020 304 patients underwent lead revision surgery of transvenous CIED in our department. Prevalence of VASO was 25.7% (n = 78), one patient was symptomatic. Independent predicting clinical parameters were male sex (2.86 (1.39-5.87), p < 0.01) and lead age (1.11 (1.05-1.18), p < 0.01)). Revision surgery despite VASO was successful in 97.4% (n = 76) without prolongation of the total surgery time or higher complication rates. Yet, lead extraction was possible in 92% of patients with VASO vs. 98.2% of patients without VASO (p 0.01). CONCLUSION: VASO is a frequent condition in patients undergoing lead revision surgery, but successful revision is feasible in most cases without preceding lead extraction. However, the lower success rates of lead extractions may be prognostically relevant, especially for younger patients.

Cardiologist-Directed Sedation Management in Patients Undergoing Transvenous Lead Extraction: A Single-Centre Retrospective Analysis.

BACKGROUND: The demand for transvenous lead extraction (TLE) has increased. In line with this, the safety of such procedures has also increased. Traditionally, TLE is performed under resource-intensive general anaesthesia. This study aims to evaluate the safety and outcomes of Cardiologist-lead deep sedation for TLE. METHODS: We retrospectively analysed 328 TLE procedures performed under deep sedation from 2016 to 2019. TLE procedures were performed by experienced electrophysiologists. Sedation was administered by a specifically trained cardiologist (bolus midazolam/fentanyl and propofol infusion). Procedural sedation data including blood pressure, medication administration and sedation time were collected. Complications related to sedation and the operative component of the procedure were analysed retrospectively. RESULTS: The sedation-associated complication rate during TLE was 22.0%. The most common complication (75% of complications) was hypotension requiring noradrenaline, followed by bradycardia requiring atropine (13% of complications). Additionally, the unplanned presence of an anaesthesiologist was needed in one case (0.3%). Deep sedation was achieved with midazolam (mean dose 42.9 ± 26.5 µg/kg), fentanyl (mean dose 0.4 ± 0.6 µg/kg) and propofol (mean dose 3.5 ± 1.2 mg/kg/h). There was no difference in medication dosage between those with a sedation-associated complication and those without. Sedation-associated complications appeared significantly more in patients with reduced LVEF (p = 0.01), renal impairment (p = 0.01) and a higher American Society of Anaesthesiologists (ASA) class (p = 0.01). CONCLUSION: Deep sedation for TLE can be safely performed by a specifically trained cardiologist, with a transition to general anaesthesia required in only 0.3% of cases. We continue to recommend the on-call availability of an anaesthesiologist and cardiac surgeon in case of major complications.

Intermediate-term performance and safety of His-bundle pacing leads: A single-center experience.

BACKGROUND: The short-term safety, feasibility, and performance of His-bundle pacing (HBP) leads have been reported; however, their longer-term performance beyond 1 year remains unclear. OBJECTIVE: The purpose of this study was to examine the intermediate-term performance and safety of HBP. METHODS: All HBP lead implants at Virginia Commonwealth University between January 2014 and January 2019 were analyzed. HBP was performed using a Medtronic SelectSecure 3830-69 cm pacing lead. RESULTS: Of 295 attempts, successful HBP implantation (selective or nonselective) was seen in 274 cases (93%). Mean follow-up duration was 22.8 ± 19.5 months (median 19.5; interquartile range 11-33). Mean age was 69 ± 15 years; 58% were males; and ejection fraction <50% was noted in 30%. Indications for pacemaker included sick sinus syndrome in 41%, atrioventricular block in 36%, cardiac resynchronization therapy in 7%, and refractory atrial fibrillation in 15%. Selective HBP was achieved in 33%. Mean HBP capture threshold at implant was 1.1 ± 0.9 V at 0.8 ± 0.2 ms, which significantly increased at chronic follow-up to 1.7 ± 1.1 V at 0.8 ± 0.3 ms (P <.001). Threshold was ≥2.5 V in 24% of patients, and 28% had an increase in HBP threshold ≥1 V. Loss of His-bundle capture at follow-up (septal right ventricular pacing) was seen in 17%. There was a total of 31 (11%) lead revisions, primarily for unacceptably high thresholds. CONCLUSION: Although HBP can prevent or improve pacing-induced cardiomyopathy, the elevated capture thresholds, loss of His-bundle capture, and lead revision rates at intermediate follow-up are of concern. Longer-term follow-up data from multiple centers are needed.

A novel approach to ICD lead revision in a patient with extensive vascular thrombosis.

Chronic extensive thrombosis of the venous system is a commonly encountered problem in end stage renal disease (ESRD) patients undergoing transvenous device implantation, lead extraction or lead revision. We describe a case of an ESRD patient with an implantable cardioverter defibrillator (ICD) that failed to deliver therapy due to lead fracture. Patient needed revision of the ICD lead system, but had extensive axillary-subclavian-superior vena cava occlusion. Patient refused a thoracotomy approach as well as lead extraction as he had a complicated course of lead extraction in the past. We successfully improvised a novel technique to revise the ICD system.

Management and long-term outcomes associated with recalled implantable cardioverter-defibrillator leads: A multicenter experience.

BACKGROUND: No comparative study of outcomes in Riata and Sprint Fidelis leads undergoing lead extraction (LE), lead abandonment (LA), and generator change only (GC) has been published. OBJECTIVES: Determine outcomes (major complications [MC]; death, extended hospitalization, or rehospitalization within 60 days [RH]; lead malfunction) of LE, LA, and GC for recalled leads. METHODS: Retrospective, multicenter, comparative study. RESULTS: A total of 298 LE, 85 LA, and 310 GC were performed. In the clinical setting of a lead intervention, there was no difference in a composite of MC, death, RH, lead revision, inappropriate shocks, or device infection between LE and LA groups (15% vs 22%, P = .140). In the clinical setting of a device at elective replacement interval (ERI), there were significantly more acute events at 60 days (MC, death, and RH) in the LE and LA groups at 15.4% (4) and 15.4% (4), and this was significantly (P = .017) higher than the GC group at 5.1% (16). There was no difference (P = 1.000) in the composite of MC, death, RH, lead malfunction, lead revisions, device infections, or inappropriate shocks between LE, LA, and GC groups at 15.4% (4), 15.4% (4), and 17.4% (54), respectively. Following generator change, 14 of 175 Fidelis leads and 3 of 135 Riata leads failed over a total of 12,714 months of follow-up. CONCLUSIONS: The failure rate of recalled leads was substantially lower compared to previous reports. It may be prudent to perform generator change only when the device is at ERI, especially when the recalled lead has historical performance that likely outweighs the risks of extraction/abandonment.