Lead Dwell Time Research Articles

Nationwide Fluoroscopic Screening of Recalled Riata Defibrillator Leads in Denmark

The natural history of insulation defects with inside-out conductor externalization in recalled St Jude Medical Riata defibrillator leads is not well understood. To determine the prevalence of externalization in a nationwide screening. Secondary aims were to examine time dependence and location of externalization, association with electrical failure, and fluoroscopic diagnostic performance. All 299 patients with recalled Riata leads in Denmark were identified, and all except one underwent fluoroscopy and device interrogation. Externalizations were confirmed by multiple investigators. The prevalence of externalization was 32 of 298 (11%) at a mean dwell time of 5.1 years. The prevalence was 21 of 98 (21%) for 8-F leads and 11 of 200 (6%) for 7-F leads; however, 8-F leads had longer dwell times. The degree of externalization was correlated with dwell time (Spearman's ρ = .37; P = .03). Externalization more often included the lead segment below the tricuspid annulus in dual coil leads than in single coil leads (69% vs 16%; P = .004). No association was observed between externalization and electrical function. Fluoroscopic diagnostic performance was good with positive and negative predictive values of 88% and 99%, respectively. The prevalence of externalization in a nationwide screening is at the same level as reported in previous studies with similar lead dwell times. The degree of externalization is time dependent, and location seems to differ between single and dual coil leads. Long-term lead performance and association with electrical failure need further clarification. Fluoroscopy has a good diagnostic performance in clinical practice.

Extraction of defibrillator leads recalled for cable externalization and failure

The Riata implantable cardioverter-defibrillator lead was recalled by the Food and Drug Administration because of an increased rate of failure associated with cable externalization. Because of its mechanical separation, the Riata lead may be challenging to extract. We therefore examined the experience with Riata lead extractions at our institution. All patients implanted with the Riata lead underwent detailed review of their electronic medical records and operative notes. Procedural complications were ascertained by reviewing the medical records up to 30 days after Riata extraction. From a total of 627 patients implanted with the Riata lead at our institution, 20 patients (age at time of extraction, 57 ± 11 years; 85 % men; lead dwell time, 48 ± 27 months) underwent lead extraction. Extraction was successful in 19 of 20 (95 %) patients and required the use of laser-powered sheaths in 18 (90 %) patients. Over a 30-day follow-up period, 1 of 20 (5 %) patients had a minor procedure-related complication consisting of a new pericardial effusion that did not require drainage. Extraction of the Riata lead seems to be successful and safe and frequently requires the use of powered sheaths.

Safety and Efficacy of Percutaneous Extraction of Endocardial Pacing Leads in Children and Adults with Congenital Heart Disease (CHD)

Methods used Retrospective data analysis of percutaneous pacing lead extractions of a single centre (November 1998 - November 2004). Summary of Results 25 patients (20 children) undergoing 27 lead extractions were identified with mean age 14.7yr (0.1 – 46 .1), mean weight 43.5 kg (3.4-88kg). Indications for pacemaker were complete heart block (20; post-surgery 14, congenital 6), defibrillator implants (2), antitachycardia pacing (2), and sinus node dysfunction (1). Indications for lead extraction were taut lead (6), high thresholds (5), insulation break (4), infection (4) and others (6). The mean duration of lead dwell time was 48.6 months (1 day –124 months). Average procedure time was 212 minutes (40 – 630 minutes) and screening time 29.5 minutes (1.3-80 minutes). Extraction stylets were used in 17 patients (Wilkoff 5, Liberator 12). Radiofrequency cutting sheathe was used in 11 and needle-eye snare in 2. Complete success achieved in 25/27 lead extractions. There were no major complications (embolism, myocardial avulsion, lead migration, haemothorax, cardiac tamponade, or death). Conclusion Percutaneous endovascular lead extraction procedures can be performed with excellent safety and success in patients with CHD.

Cardiac pacemaker lead extraction using conventional techniques:a single centre experience

Background: New methods of lead extraction using laser sheath devices are under evaluation but these techinques are not available in the majority of centres and have cost implications. Furthermore, in the absence of comparative randomised trials, registry experience with new devices must be judged against contemporary data using conventional methods. We report a single centre series of pacemaker lead extraction using conventional methods. Methods: Study Population: Attempted extraction of 165 leads during 95 procedures in 80 patients. Leads had been in place (dwell time) for a mean of 76 months (range 0.2–248.4 months). Indications for lead extraction: infection (41.1%), skin erosion (9.5%), advisory leads (12.6%), faulty leads (12.6%), other (24.2%). Extraction techniques: traction and/or locking stylets and dilator sheaths (89.7%), Byrd workstation (6.1%) and open thoracotomy (4.8%). Results: Complete removal was achieved for 143 leads (86.7%), partial removal in 12 leads (7.3%) and 10 (6.1%) could not be removed. A shorter lead dwell time was associated with extraction success in both univariate ( p=0.0004) and multivariate analyses ( p<0.0001). There was a trend for a higher rate of success in atrial rather than ventricular leads (93.2% v 80.9%, p=0.052). Active fixation, patient gender, age and indication for lead extraction had no bearing on outcome. Complications: There were no deaths. Major complications occurred in 3 patients (3.2%): pericardial tamponade (1), pulmonary embolus (1) and stroke (1). Significant bleeding (requiring blood transfusion) occurred in 11 procedures (12%). Conclusions: Cardiac lead extraction using conventional methods has a high success rate of 86.7%. Success was significantly related to a shorter lead dwell time. Further prospective randomised trials are needed to compare traditional techniques with laser extraction both in terms of clinical outcome and cost-effectiveness.

The effect of modulated high frequency condenser field on the straub-fuehner frog heart preparation: Fenning, C., and Mott, C. R.: Am. J. Physiol. 144: 1, 1945

Many clinicians use the strategy of prophylactically placing an endovascular balloon before transvenous lead extraction, yet there are no data regarding this practice.This study assesses long-term outcomes of prophylactic placement of an endovascular balloon in the venae cavae of patients during transvenous lead extraction.From April 1, 2016 to March 31, 2017 data were prospectively collected at 2 international cardiovascular centers on patients who had the balloon prophylactically placed in the venae cavae. Patients were monitored for a minimum of 3 months to capture any associated adverse events.Twenty-one patients had the balloon prophylactically placed in the venae cavae during lead extraction. Sixteen patients were male (76%); the mean age was 57.6 ± 18.7 years; and the mean body mass index was 26.1 ± 4.4 kg/m2. The mean lead dwell time was 11.2 ± 8.3 years, with an average of 2.2 ± 1.1 leads per case, and most indications for extraction were noninfectious (62%). Two minor complications (10%, pocket hematomas) and 1 major complication (5%, cardiac tamponade) occurred during the procedure. All cases (100%) were procedural successes, and all patients (100%) were discharged alive. On follow-up (6.8 ± 3.7 months), all patients were alive and reported no adverse events related to prophylactic balloon placement, such as pulmonary emboli or deep venous thrombi.During the study period, we observed no acute or long-term adverse outcomes associated with prophylactic placement of an endovascular balloon in the venae cavae of patients undergoing transvenous lead extraction.