Lead Fracture Research Articles

Clinical Summaries

Fractures of pace-sense electrodes in implantable cardioverter-defibrillator patients are a common cause of inappropriate shocks. To reduce inappropriate shocks, we developed a lead-integrity alert (LIA) triggered by either oversensing or high impedance that can be downloaded into previously implanted implantable cardioverter-defibrillators. This prospective study tested the hypothesis that the LIA would reduce the percentage of patients who receive inappropriate shocks compared with a concurrent control group monitored by impedance only. Each group included a prospectively determined sample size of 213 consecutive patients with fractures confirmed by structural analysis of explanted leads. The LIA group had a 46% relative reduction (95% confidence interval 34% to 55%) in the percentage of patients with ≥1 inappropriate shock (LIA 38% versus control 70%, P <0.001) and a 50% relative reduction (95% confidence interval 33% to 61%) in the percentage with ≥5 shocks (25% versus 50%, P <0.001). These data show that a software download that upgrades previously implanted implantable cardioverter-defibrillators without surgical revision reduces inappropriate shocks caused by lead fractures. See p 1449. Twin-twin transfusion syndrome is an important cause of perinatal mortality in monochorionic twins, often because of cardiovascular compromise associated with increased intravascular volume in the recipient twin. In this autopsy study of 11 sets of twins with the condition, 4 recipient twins had anomalous mitral arcade, a rare fibrotic valve lesion that is associated with regurgitation. Previously unrecognized in twin-twin transfusion syndrome, anomalous mitral arcade may explain many of the progressive hemodynamic abnormalities in this condition. From this retrospective clinicopathological correlation study, ultrasound/echocardiographic evidence of left atrial dilation and significant mitral regurgitation in the recipient should raise suspicion for anomalous mitral arcade, a structural lesion that likely will not reverse after successful laser treatment or delivery of the fetus, as other hemodynamic and functional abnormalities often do. Thus, for perinatologists …

Psychological Adjustment in ICD Patients Living With Advisory Fidelis Leads

Psychological Adjustment and Fidelis ICD Leads. Implantable cardioverter defibrillators (ICD) advisory notices present treatment dilemmas for physicians and patients. On one side, the risk of device malfunction and the likely severity of clinical sequelae have to be estimated. This estimate has to be weighed against the risks of surgery to replace the advisory component. It is unclear whether there is important psychological morbidity associated with living with an ICD under advisory and whether this should be factored into decision making. The study had 2 objectives: (1) to examine whether there is adverse psychological adjustment when an ICD is under advisory, and (2) to assess the psychological sequel of advisory ICD component malfunction. This study focused on the Sprint Fidelis advisory. All patients in our practice who still had an in service Medtronic Fidelis lead were included in the study. Three groups were compared: advisory group but no fracture (n = 249), advisory group with lead fracture (n = 24), and a control group (n = 143). For both objectives, we used a general anxiety and depression instrument and also device-specific measures of psychological well being. First, there was no evidence of differences in the psychological functioning of patients at risk of ICD lead malfunction compared to a control group. Second, patients who had experienced an ICD lead fracture had adverse psychological morbidity compared to control patients, and this appeared, primarily, to be related to receiving inappropriate shock(s) at the time of the fracture.

Surgical Approaches to Epicardial Pacemaker Placement: Does Pocket Location Affect Lead Survival?

Permanent cardiac pacing in pediatric patients presents challenges related to small patient size, complex anatomy, electrophysiologic abnormalities, and limited access to cardiac chambers. Epicardial pacing currently remains the conventional technique for infants and patients with complex congenital heart disease. Pacemaker lead failure is the major source of failure for such epicardial systems. The authors hypothesized that a retrocostal surgical approach would reduce the rate of lead failure due to fracture compared with the more traditional subrectus and subxiphoid approaches. To evaluate this hypothesis, a retrospective chart review analyzed patients with epicardial pacemaker systems implanted or followed at Rady Children’s Hospital San Diego between January 1980 and May 2007. The study cohort consisted of 219 patients and a total of 620 leads with epicardial pacemakers. Among these patients, 84% had structural congenital heart disease, and 45% were younger than 3 years at time of the first implantation. The estimated lead survival was 93% at 2 years and 83% at 5 years. The majority of leads failed due to pacing problems (54%), followed by lead fracture (31%) and sensing problems (14%). When lead failure was adjusted for length of follow-up period, no significant differences in the rates of failure by pocket location were found.

Salvage of a Failing Bifurcated Bipolar Epicardial Lead With Conductor Fracture

Cardiac rhythm abnormalities in children are often managed by using epicardial pacing systems. Lead failure poses a serious problem in pacemaker-dependent patients. We describe a lead repair that was not intuitive and avoided repeat thoracotomy in a pacemaker-dependent patient with lead fracture.

The Controversy around the Most Optimal Lead Anchoring Technique

Dear Editor, We appreciate Dr Colvin's thoughtful review and agree “that current anchoring devices suffer from unpredictable lead retention, possible lead fracture and discomfort due to being bulky.” As noted, our study was intended to analyze leads following maximal tension applied to suture loop anchors. The leads were subsequently examined under gross microscopy and tested for impedance changes. This was not a longitudinal study and interpretation of our results was therefore limited. Anecdotally, we recently explanted a lead in a patient who had a spinal cord stimulator system in place for over 1 year. At the time of implant, the lead was anchored with 2.0 silk loop anchors. Following explantation, the lead was …

Impact to Spinal Cord Stimulator Lead Integrity with Direct Suture Loop Ties: Commentary on Kreis et al. (2009)

Dear Dr. Paul G. Kreis et al., I read with great interest your article “Impact to Spinal Cord Stimulator Lead Integrity with Direct Suture Loop Ties” [1]. It is acknowledged that current anchoring devices suffer from unpredictable lead retention, possible lead fracture, and discomfort due to being bulky. As an alternate to existing anchors, this study examined a direct suture fixation technique. This study clearly shows no gross lead damage using this technique in the short term. These results are preliminary as spelled out in the report. However, this study raises many important issues regarding the direct suturing of spinal cord stimulator leads. It is now common practice for stimulation leads to be manufactured with outer polyurethane …

Contributions of remote monitoring to the follow-up of implantable cardioverter-defibrillator leads under advisory

AimsAutomatic daily transmission of data from implantable cardioverter–defibrillators (ICDs) enables the remote monitoring of device status and leads function. We report on a 2-year experience with remote monitoring in 40 recipients of high-voltage ICD leads, prone to fracture and under advisory since October 2007.Methods and resultsThe ICDs were remotely monitored as well as systematically interrogated in the ambulatory department every 3 months. The patients were also seen in case of abnormal lead impedance, or other manifestations consistent with lead dysfunction. Over a mean follow-up of 22 ± 4 months after ICD implantation, four lead dysfunctions were suspected because of remotely transmitted oversensing of noise artifacts, abrupt rise in pacing impedance, or both. A lead fracture needing lead replacement was confirmed in three patients (7.5%), two of them before any inappropriate therapy and one after the delivery of three inappropriate shocks. No lead failure was observed in the remaining 36 patients, either at the time of ambulatory visits or during remote monitoring.ConclusionRemote monitoring allowed the early and reliable detection of ICD leads failure without requiring any patient intervention.

Chest Radiographs Are Valuable in Demonstrating Clinically Significant Pacemaker Complications That Require Reoperation

Purpose To evaluate the utility of chest radiography in demonstrating clinically significant pacemaker complications that required reoperation. Methods In this retrospective case-controlled series, we identified 14 consecutive adults who required pacemaker reoperation and who had chest radiographs available for review (6 men, 8 women; mean age, 71 years [range, 43–95 years]). Ten patients had pacemakers implanted at our institution, and 4 were referred for reoperation. Forty-two controls, 3 for each patient, had postoperative chest radiographs and normal device function (25 men, 17 women; mean age 76 years [range, 37–96 years]). All postoperative chest radiographs, including 1-year follow-ups, were blindly reviewed by at least 2 of 4 radiologists for lead perforation and position of right atrial and right ventricular leads. Follow-up radiographs were assessed for lead perforation, lead displacement, and lead fracture. Data were analysed by using the Fisher exact test. Results Of the patients, 1.7% (10/581) required reoperation for pacemaker dysfunction (noncapture, oversensing, abnormal atrial and ventricular thresholds, failing impedance), extracardiac stimulation, and lead perforation and/or displacement. There were no lead fractures. Chest radiographs demonstrated pacemaker complications in 57% of patients (8/14) at a median of 2 days (<1–32 days) after implantation and in 5% of the controls (2/42) ( P < .0001). None of the abnormalities were noted on the official reports. Among subgroups, chest radiographs were abnormal for the following indications: pacemaker dysfunction in 4 of 7 patients versus 0 of 21 controls ( P = .0017), extracardiac stimulation in 1 of 3 patients vs 0 of 9 controls ( P = .25), and lead perforation and/or displacement in 3 of 4 patients vs 2 of 12 controls ( P = .06). Conclusions Chest radiographs are useful after pacemaker placement and demonstrate the majority of complications that require reoperation. Familiarity with the expected normal position of the leads, appearances of pacemaker complications, and comparison with prior radiographs is crucial in rendering a correct diagnosis that guides patient management.

A completely subcutaneous implantable cardioverter defibrillator system functioning simultaneously with an endocardial implantable cardioverter defibrillator programmed as pacemaker

Because of multiple ventricular lead fractures with inappropriate shocks, a 31-year-old male received a completely subcutaneous implantable cardioverter defibrillator (ICD) system with the already existing 'endocardial' ICD functioning as an atrial pacemaker.

Risk Factors for Implantable Defibrillator Lead Fracture in a Recalled and a Nonrecalled Lead

The Medtronic Sprint Fidelis implantable cardioverter defibrillator (ICD) lead was "recalled" in October 2007 after 268,000 implants worldwide due to increased failure risk. Manufacturer suggested monitoring has not been shown effective at preventing adverse events. Only limited data exist regarding clinical predictors of Fidelis lead fracture. We sought to identify risk factors for Fidelis fracture to guide clinical monitoring and compare its performance with a control lead. Fractured lead cases were retrospectively reviewed for demographic data, implant technique, radiographic appearance and clinical presentation was analyzed. Lead survival was compared using Kaplan-Meir curves. Study patients (n = 1314) experienced 18 Fidelis and 6 Quattro lead fractures. Patients with failed Fidelis leads were younger than those with surviving leads (49.5 vs 64.6 years, P = 0.0066). Fidelis lead fractures often occurred around the time of physical activity. No other measured demographic or technique related factors were associated with lead fracture. Fidelis leads had significantly decreased survival compared with Quattro leads (89.3 vs 98.9% at 30 months). Patients less than 50 years old had significantly decreased lead survival compared with those older than 50 in both Fidelis (79.6% vs 96.5% at 24 months) and Quattro (93.4 vs 99.8%, P < 0.001 at 24 months) leads. Patients under age 50, with either Fidelis or Quattro ICD leads, are at increased risk of lead fracture compared with patients over 50, particularly around the time of intense physical activity. Aggressive monitoring and advisory programming appears warranted in patients with Fidelis leads as well as especially in younger patients.

Long-term follow-up after steroid-eluting epicardial pacemaker implantation in young children: a single centre experience

The purpose of this paper is the retrospective investigation of the clinical outcome and modes of failure leading to reoperation, as well as the report of the long-term results, in a group of young children who underwent epicardial pacemaker implantation. Between 2000 and 2008, 45 young children underwent epicardial pacemaker implantation at 3.2 +/- 2.5 years of age for congenital (n = 27) or post-operative (n = 18) atrioventricular block. The follow-up time was 5.7 years +/- 5 months (range: 6 months to 7.3 years). Five lead malfunction events (11%) were detected during the follow-up time, three of which were due to ventricular lead fracture. All revisions could be performed without complications, and all revised pacemakers showed stable pacing and sensing parameters during long-term follow-up. The actuarial freedom from reoperation at 6 years was 88.8 +/- 2%. Median epicardial ventricular and atrial pacing thresholds were stable and excellent at the latest follow-up, with means of 1.1 +/- 0.5 V and 0.7 +/- 0.8 V, respectively. In our patient cohort of 45 young children, epicardial pacing was associated with a satisfactory clinical outcome and acceptable long-term results. The major cause of reoperation in our series was lead fracture. Reoperations were performed at a low risk.

Fracture of Epicardial Resynchronization Lead Caused by Deceleration Injury

A 50-year-old man with heart failure, systolic dysfunction, and abnormal septal motion underwent ventricular resynchronization. Postoperative clinical and echocardiographic improvement was observed. Several months later, he complained of worsening functional class after a traffic accident. Pacing lead fracture was diagnosed. After replacing the lead, improvement of clinical condition and ventricular parameters was achieved. The role of seat belts in causing dysfunction of pacemakers and resynchronization devices after deceleration injury is discussed.

142: Lead Fractures in Left Ventricular Assist Devices – A Multi-Institutional Experience

142: Lead Fractures in Left Ventricular Assist Devices – A Multi-Institutional Experience

Causes of ventricular oversensing in implantable cardioverter-defibrillators: Implications for diagnosis of lead fracture

Implantable cardioverter-defibrillator (ICD) ventricular oversensing may result in inappropriate therapy, which may be triggered by lead/connection issues that require surgical revision or physiologic oversensing that may be resolved with reprogramming. The sensing integrity counter (SIC) is an oversensing diagnostic that increments for very rapid ventricular intervals < or =130 ms. The purpose of this study was to determine the causes of a high SIC and the ability of additional diagnostics to differentiate lead/connection issues from other causes of oversensing for patients with normal impedance. Frequent SICs were identified in patients during routine follow-up visits. To diagnose the cause of oversensing, patients wore a modified 24-hour digital Holter monitor that recorded ECG, ventricular electrogram, and the ICD Marker Channel (Medtronic). Recordings were reviewed to determine the causes of oversensing. Patients with confirmed oversensing and adequate data were analyzed. The number of SICs per day and the presence of a nonsustained tachycardia (NST) episode with ventricular mean cycle length <220 ms were retrieved from stored ICD data. Forty-eight patients had a median of 13 SICs/day. Presumed lead/connection issues occurred in 23% of patients, whereas physiologic oversensing occurred in 77% of patients. A rapid NST was recorded more commonly in patients with lead/connection issues than in those without (9/11 vs 1/37; P < .0001). Oversensing resulting in frequent, very short intervals typically are caused by either lead/connection issues or physiologic signals. The additional finding of rapid NSTs usually indicates a lead/connection issue, even in the absence of impedance abnormalities.

Novel Use of Intraoperative Dexmedetomidine Infusion for Sedation During Spinal Cord Stimulator Lead Placement via Surgical Laminectomy

Background: Spinal cord stimulators are most often placed through a percutaneous approach using minimal sedation and local anesthesia to facilitate intraoperative testing. However, when leads need to be placed using a laminectomy incision additional anesthesia is required which can complicate intraoperative testing. There is no consensus as to the best anesthetic choice when laminectomy-placed leads are required. Objective: We present 2 cases where spinal cord stimulator leads were implanted through a surgical laminectomy under sedation using dexmedetomidine infusion and local anesthesia to provide a cooperative patient for intraoperative testing. Case Report: Patient #1: A 40-year-old female with Complex Regional Pain Syndrome secondary to an automobile accident who had good pain control with a spinal cord stimulator until a lead fracture resulted in loss of stimulation. She required a laminectomy-placed lead which was implanted under dexmedetomidine infusion and local anesthesia. Patient #2: A 54-year-old female with Failed Back Syndrome who had good pain control until a lead fracture resulted in loss of stimulation. She underwent a laminectomy-placed lead, new battery pocket, and removal of the old system under a dexmedetomidine infusion and local anesthesia. Limitations: Report of only 2 cases. Conclusions: The anesthetic management from a laminectomy-placed spinal cord stimulator can present a difficult choice. A general anesthetic or even deep sedation can provide good operative conditions but limits intraoperative testing or in the case of deep sedation risks losing the airway in the prone position. On the other hand, minimal sedation, which facilitates intraoperative testing, can make the surgical procedure extremely uncomfortable or even unbearable. Dexmedetomidine infusion and local anesthesia provide sedation for the operative portions while rendering the patient alert and cooperative during intraoperative testing. Key words: Spinal Cord Stimulator, dexmedetomidine, percutaneous, laminectomy, intraoperative, sedation

Implantable Cardioverter-Defibrillator Lead Extraction by Conventional Traction and Counter-Traction Technique

A 46-year-old man presented to our institution with inappropriate implantable cardioverter-defibrillator (ICD) shock delivery. The ICD (single chamber, dual shock coils) was implanted for sustained monomorphic ventricular tachycardia with unstable hemodynamics and underlying systolic left ventricular dysfunction. ICD interrogation revealed recurrent episodes of ICD shock due to noise sensing and increased impedance of right ventricular (RV)-lead. With the impression of lead fracture, ICD lead extraction was performed. The fractured ICD lead was completely removed by traction of locking stylet and counter-traction of polypropylene dilator sheath. A new lead was inserted and the patient was discharged without complications after 2 days. To our knowledge, this is the first report on ICD lead extraction by conventional traction and counter-traction technique in Korea.

A 15-Year Experience With Permanent Pacemaker and Defibrillator Lead and Patch Extractions

The value of extraction of infected or hazardous epicardial and endocardial pacemaker and internal cardioverter defibrillator (ICD) leads is well established. Recent reviews including all leads and patches are lacking. This review describes experience with open and percutaneous techniques, including all lead types and indications. With Institutional Review Board approval, we reviewed charts of all adults and children undergoing extraction of permanent pacemaker and ICD leads and patches by a single operator between 1993 and 2008. Overall, 145 leads and 7 patches were removed from 79 patients. Dwell time averaged 56.2 months. The commonest indications for extraction were infection (73.4%) or risk of lead fracture (20.3%). Most leads (84.2%) were extracted percutaneously. Removal was complete for 131 leads (86.2%) and partial in 14. Incomplete lead removal was rarely associated with clinical complications. Minor complications occurred in 6 patients (7.6%) and major complications occurred in 3 (3.8%). The major complication rate was 16.7% for the open group and 1.5% in the percutaneous group. Pacemaker and ICD infections generally respond to antibiotics, complete hardware removal, and a hardware free interval. However, these principles cannot always be invoked, and the risk of complications is likely to increase when hardware cannot be completely removed or when a hardware-free interval is unsafe or inadvisable. Percutaneous lead extraction is superior to open extraction in terms of safety and comfort, but epicardial extraction techniques remain critically important in selected patients.

Lead Fractures in Deep Brain Stimulation during Long-Term Follow-Up

The purpose was to determine the incidence of lead fracture in patients with DBS over a long period of time. We present a retrospective study of 208 patients who received 387 DBS electrodes. Fourteen patients had sixteen lead fractures (4% of the implanted leads) and two patients suffered from 2 lead fractures. Of all lead fractures, five patients had the connection between the leads and the extension cables located in mastoids region, ten in cervical area and one in thoracic region. The mean distance from the connection between the electrode and the extension cable and the lead fracture was 10.7 mm. The lead fracture is a common, although long-term complication in DBS surgery. In our experience, the most common site of electrode cable breakage is approximately between 9 and 13 mm from the junction between the lead and the extension cable. The most important cause of lead fracture is the rotational movement of the lead-extension cable system. If we suspect lead fracture, we must check the impedance of the electrode and to evaluate the side effects of voltage. Finally, we must conduct a radiological screening.

Predictors of Fracture Risk of a Small Caliber Implantable Cardioverter Defibrillator Lead

The Sprint Fidelis 6949 implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a high rate of fracture. Identification of predictors of subsequent fracture is useful in decision making about lead replacement and for future lead design. We sought to determine if there are clinical, procedural, or radiological features associated with a greater risk of subsequent lead fracture. Patients with Sprint Fidelis 6949 lead fractures (Fracture group) were identified from our institutional database. Each patient in the Fracture group was matched to two controls, immediately preceeding and succeeding Sprint Fidelis 6949 implant. Clinical and procedural characteristics were compared. Chest radiographs performed 2 weeks after ICD implant were reviewed by an observer blinded to outcomes. The following features were assessed: ICD tip location, lead slack, kinking of the lead body (> or =90 degrees ), and presence of lead "crimping" within the anchoring sleeve. Twenty-six patients with Sprint Fidelis 6949 lead fractures were identified and were matched to 52 control patients. On univariate analysis, a higher left ventricular ejection fraction (LVEF), prior ipsilateral device implant, history of prior ICD lead fracture, and noncephalic venous access were associated with risk of lead fracture. On multivariate analysis, a higher LVEF was the only independent predictor of lead fracture (P = 0.006). Radiological features were similar between the two groups. In this study, a higher LVEF was associated with a greater risk of lead fracture in patients with Sprint Fidelis 6949 ICD leads. Radiographic features did not predict subsequent risk of lead fracture in our population. (PACE 2010; 437-443).

Use of a Custom‐Designed Adapter to Manage ICD Lead Fracture

We report the case of a 72-year-old patient with ischemic cardiomyopathy who was found to have a lead fracture in the RV coil DF-1 connector of an integrated bipolar implantable cardioverter-defibrillator (ICD) lead system at the time of upgrade to a biventricular ICD. Due to the redundant connection of the RV coil to the DF-1 connector and the ring on the IS-1 connector, a custom-designed adapter was used to exclude the site of fracture. This novel solution spared the patient the potential risks of lead extraction or abandoning the fractured ICD lead. In this way, pacing and defibrillating capabilities were fully restored, providing the patient 6 years of optimal device functioning.