Active Fixation Coronary Sinus Lead Research Articles

Effective and safe long-term transvenous extraction of the novel active fixation coronary sinus lead

Active fixation systems for leads in the coronary system minimize the risk of micro and macro dislodgement. However, extracting these leads is riskier than in the case of leads of passive fixation. This was confirmed by the results of the extraction of Medtronic StarFix lead. The new Medtronic 20066 Attain Stability lead was designed to combine the stability of fixation with the feasibility of extraction. In our report, we present the case of extraction of 36th month Medtronic 20066 Attain Stability lead. The lead was safely and entirely extracted with simple traction after securing with a locking stylet without visible damage to either the fixating mechanism or coronary veins. Our experience suggests that extraction of the Medtronic 20066 Attain Stability lead even after relatively long dwelling time seems to be substantially simpler and safer than the extraction of Medtronic StarFix lead.

Ratchet mechanism selectively causing idiopathic macrodislodgement of an active-fixation coronary sinus lead: a case report.

Background ‘Idiopathic’ lead macrodislodgement may be due to Twiddler’s syndrome depending on active twisting of pulse generator within subcutaneous pocket. All leads are involved, at any time from implantation, and frequently damaged. In the past few years, a reel syndrome was also observed: retraction of pacemaker leads into pocket without patient manipulation, owing to lead circling the generator. In other cases, a ‘ratchet’ mechanism has been postulated. Reel and ratchet mechanisms require loose anchoring, occur generally briefly after implantation, with non-damaged leads. We report the first case of an active-fixation coronary sinus lead selective macrodislodgement involving such ratchet mechanism. Case summary A 65-year-old man underwent biventricular defibrillator device implantation, with active-fixation coronary sinus lead. Eight months later, he complained of muscle contractions over device pocket. At fluoroscopy, coronary sinus lead was found near to pocket, outside of thoracic inlet. Atrial and ventricular leads were in normal position. After opening pocket, a short tract of coronary sinus lead appeared anteriorly dislocated to generator, while greater length of lead body twisted a reel behind. The distal part of lead was found outside venous entry at careful dissection. Atrial and ventricular leads were firmly anchored.Discussion Our case is a selective ‘Idiopathic’ lead macrodislodgement, possibly due to a ratchet mechanism between the lead and the suture sleeve, induced by normal arm motion; such mechanism incredibly, and for first time in literature involves a coronary sinus active-fixation lead.Conclusion Careful attention should always be paid to secure anchoring even of active-fixation coronary sinus leads.

P5681Improved electrical performance/stability of a novel active fixation coronary sinus lead compared to passive fixation leads: a multi-centre study

Abstract Background A novel active fixation coronary sinus (CS) lead, Attain Stability, has been released in a bipolar and quadripolar configuration, with the hypothesis it will improve targeted lead positioning and stability independent of vessel anatomy. Purpose To compare implant procedure parameters and electrical performance/stability of a novel active fixation lead with passive fixation CS leads. Methods This was a retrospective study involving 6 major UK cardiac centres. Patients who received active leads were compared with passive lead recipients in a 1:2 ratio. The primary outcome was total lead displacements (combined macro/micro-displacements, defined as displacements requiring repositioning procedures, or an increase in threshold≥0.5 volts or pulse width≥0.5msec, or a change in pacing polarity). Multivariate analysis was performed to establish predictors of the primary outcome, assessing fixation mechanism (active or passive), number of poles (quad or bipolar), contributing hospital and follow-up duration. Results 736 patients were included (241 with active leads, 495 with passive leads). There were no group differences in the baseline characteristics with respect to age, gender, EF, NYHA class, and co-morbidities, P>0.05 for all. The primary endpoint rate was 31% (74/241) in the active and 43% (213/495) in the passive fixation group (P=0.002). 6 patients in the active group and 14 in the passive group required CS lead repositioning procedures. The results of the multivariate analysis are presented in the Table. The use of active leads was associated with a significant reduction in lead displacements, odds ratio 0.62 (95% CI 0.43–0.9), P=0.012. There were differences in favour of passive compared with active leads in procedure duration, 120 [96–149] minutes vs 128 [105–155] minutes (P=0.011), and fluoroscopy time, 17 [11–26] minutes vs 18.5 [13–27] minutes (P=0.028). The median duration of follow up was similar (active vs passive): 31 [17–47] weeks vs 34 [16–71] weeks, (P=0.052). Odds Ratio (95% Confidence Interval) P-value Active fixation CS lead 0.62 (0.43–0.9) 0.012 Quadripolar (rather than Bipolar) lead 1.26 (0.75–2.11) 0.376 Follow-up Duration (weeks) 1.005 (1.001–1.008) 0.025 Also included in the model: contributing hospital, which was significant. Conclusion In this large, multi-centre study, active fixation Attain Stability CS leads demonstrated superior electrical performance/stability compared with passive fixation leads, with minimal increases in implant procedure and fluoroscopy times. Acknowledgement/Funding None

Efficacy, Safety, and Performance of Isolated Left vs. Right Ventricular Pacing in Patients with Bradyarrhythmias: A Randomized Controlled Trial

Background Considering the potential deleterious effects of right ventricular (RV) pacing, the hypothesis of this study is that isolated left ventricular (LV) pacing through the coronary sinus is safe and may provide better clinical and echocardiographic benefits to patients with bradyarrhythmias and normal ventricular function requiring heart rate correction alone.Objective To assess the safety, efficacy, and effects of LV pacing using an active-fixation coronary sinus lead in comparison with RV pacing, in patients eligible for conventional pacemaker (PM) implantation.Methods Randomized, controlled, and single-blinded clinical trial in adult patients submitted to PM implantation due to bradyarrhythmias and systolic ventricular function ≥ 0.40. Randomization (RV vs. LV) occurred before PM implantation. The main results of the study were procedural success, safety, and efficacy. Secondary results were clinical and echocardiographic changes. Chi-squared test, Fisher's exact test and Student's t-test were used, considering a significance level of 5%.Results From June 2012 to January 2014, 91 patients were included, 36 in the RV Group and 55 in the LV Group. Baseline characteristics of patients in both groups were similar. PM implantation was performed successfully and without any complications in all patients in the RV group. Of the 55 patients initially allocated into the LV group, active-fixation coronary sinus lead implantation was not possible in 20 (36.4%) patients. The most frequent complication was phrenic nerve stimulation, detected in 9 (25.7%) patients in the LV group. During the follow-up period, there were no hospitalizations due to heart failure. Reductions of more than 10% in left ventricular ejection fraction were observed in 23.5% of patients in the RV group and 20.6% of those in the LV group (p = 0.767). Tissue Doppler analysis showed that 91.2% of subjects in the RV group and 68.8% of those in the LV group had interventricular dyssynchrony (p = 0.022).Conclusion The procedural success rate of LV implant was low, and the safety of the procedure was influenced mainly by the high rate of phrenic nerve stimulation in the postoperative period.

Coronary Venous Lead Extraction.

The increasing number of cardiac resynchronization therapy devices implanted, coupled with the increasing incidence of cardiac implantable electronic device infection, has led to a greater need for extraction of coronary venous pacing leads. The objectives of this study were to review the indications, techniques and published results of coronary venous lead extraction. In this study, we searched PubMed using the search terms “lead extraction,” “coronary sinus,” “coronary venous,” “pacing,” and “cardiac resynchronization therapy” for relevant papers. The reference lists of relevant articles were also searched, and personal experience was drawn upon. Published success rates and complications were found to be similar to those reported for non-coronary venous leads in experienced centers. However, reimplantation success differs and can be limited by vessel occlusion postextraction. The available active fixation coronary sinus lead (Attain Starfix™; Medtronic, MN, USA) is a particularly complex lead to extract, whereas limited data on the newer active fixation leads (Attain Stability™, Medtronic, MN, USA) suggest that they are less challenging to remove. The study concluded that coronary venous lead extraction presents unique challenges, especially reimplantation, that require special consideration and planning to overcome.

Extraction of an Infected Active Fixation Coronary Sinus Lead with the Aid of a Tissue Stabilizer

We present a 49-year-old man who required extraction of a cardiac resynchronization device due to lead infection. While 2 leads were successfully retrieved by a transvenous approach the third one with active fi xation and entrapped into a coronary sinus side-branch

Active fixation coronary sinus lead extraction – A safe procedure

Active fixation coronary sinus lead extraction – A safe procedure

Active fixation coronary sinus lead extraction – A safe procedure

© 2016 Sociedade Portuguesa de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.

Removal of a chronically implanted active-fixation coronary sinus pacing lead using the Cook Evolution(C) lead extraction sheath

In this case, a unipolar active-fixation coronary sinus lead (Star Fix®) had to be removed because of severe infection. For lead removal, a venous lead entry site approach with a transvenous mechanical dilator technique was …

The Active Fixation Coronary Sinus Lead: More Peril than Promise?

The Active Fixation Coronary Sinus Lead: More Peril than Promise?

Fibrotic Tissue Growth into the Extendable Lobes of an Active Fixation Coronary Sinus Lead Can Complicate Extraction

Extraction of passive fixation coronary sinus (CS) leads is typically easily achieved with manual traction. The ability to readily extract active fixation leads from the CS is less clear. Our first extraction experience with an active fixation CS lead was in a 58-year-old man with a 13-month-old Medtronic 4195 lead (Medtronic Inc., Minneapolis, MN, USA). The lobes of the lead would not fully undeploy. Significant, prolonged manual traction was required to free the lead from the cardiac vein. Inspection demonstrated fibrotic tissue growth into the lead lobes. Such growth may lead to an increase in extraction complications and failures.

Improved success rate of cardiac resynchronization therapy implant by employing an active fixation coronary sinus lead

Cardiac resynchronization therapy (CRT) is the standard treatment for heart failure with severe reduced left ventricular (LV) function and wide QRS complex. Coronary sinus (CS) lead implantation is challenging and accompanied by substantial dislocation rates. We evaluated the usage of an active fixation LV lead (Attain Starfix, Medtronic, MN, USA) with deployable lobes in challenging lead positions. Between September 2006 and August 2009, 678 CRT devices were implanted. In 82 patients (12%) (59 male, 70 +/- 10 years, 39 ICM, 41 DCM, 2 valvular CM, LVEF 28 +/- 9%, NYHA 3.0 +/- 0.4, QRS 169 +/- 29 ms), the Attain Starfix active fixation lead was used. The main reason was intra-operative dislodgement of one (n = 47) or two (n = 5) passive fixation leads during implantation or revision procedure (n = 30). Active fixation lead implantation was overall successful with 90% (n = 74). Anatomical peculiarity was mostly an optimal lead position in otherwise unstable proximal parts of the target vein or a circumscripted areal of optimal threshold without phrenic nerve stimulation. At median follow-up of 99 days the threshold remained stable (1.2 +/- 0.8 vs. 1.0 +/- 0.5 V at 0.5 ms). Revisions due to instability in ectatic vein (n = 1) after 12 months and extractions (n = 2) because of device perforation/infection after 6/15 months were performed without complication. The Attain Starfix active fixation lead proved to be an important option in anatomically challenging, otherwise unstable positions often located in the proximal part of the target vein. Lead revisions or extractions as late as 15 months after implantation were feasible.

Initial Japanese experience and long-term follow-up with a new active fixation coronary sinus lead, the StarFix 4195

Technologies associated with cardiac resynchronization therapy (CRT) devices and lead systems have progressed. However, dislocation after coronary sinus (CS) lead placement continues to be a problem. Furthermore, CS lead positioning at the site of the ventricular latest activation (detected by echocardiography) is often problematic due to large vessel size leading to the lead placement (wedge site) near the apical site. The newly available active fixation CS lead (StarFix 4195) enabled us to anchor the CS lead at the target site regardless of vessel size and availability of a wedge site. We report on seven patients who had previously failed conventional CS lead positioning due to large vessel size and a low phrenic nerve stimulation threshold at the optimal site and lack of stabilization followed by dislocation at the target vein. We attempted to replace the original lead with the StarFix 4195. All patients successfully underwent StarFix 4195 lead replacement at the target site and responded to CRT in the long-term follow-up period.

The story of an active fixation coronary sinus lead: Promise and peril

The benefits of cardiac resynchronization therapy are well established. Patient outcomes depend on successful implantation of a left ventricular lead in a physiologically advantageous site that is stable with an acceptable acute and chronic pacing threshold and shows short- and long-term freedom from diaphragmatic or chest wall stimulation. The currently available passive fixation coronary sinus (CS) leads rely on their characteristic shape and size to remain stable in a CS branch. As such, anatomy dictates lead selection.

Chronic performance of an active fixation coronary sinus lead

Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure. Optimal left ventricular (LV) lead placement is useful in enhancing response from CRT. Three significant obstacles to LV lead placement are patient-specific variations in coronary venous anatomy, phrenic nerve stimulation, and a significant rate of LV lead dislodgement or microdislodgement. The primary objective of this study was to determine the safety and effectiveness of the Medtronic StarFix active fixation LV lead. Secondary objectives evaluated implant success, lead placement and procedure time, lead handling and lobe deployment, additional electrical performance, and all adverse events reported in the study. There were 441 patients enrolled in this multicenter study. Standard cardiac resynchronization therapy (CRT) inclusion criteria were used. Patients were followed up for a mean of 23 months. Implant data, success with CRT, LV lead performance, clinical outcomes, and experience with LV lead revisions were prospectively evaluated. The mean LV stimulation threshold at implant was 1.3 +/- 1 volts and was stable over time. Sensing was also excellent. In 96.3% of the implantations in this study, the physician was able to place the lead in a nonanterior position. Extracardiac (phrenic nerve) stimulation required invasive intervention in 11 subjects (2.5%). Only 3 dislodgements (0.7%) were observed. Two occurred in the first 5 implants and were attributed to inadequate engagement of the venous subbranch. The Medtronic 4195 is safe and highly efficacious. It affords the physician more choices in lead placement location and has a remarkably low dislodgement rate.

Reversing cardiac resynchronization therapy non-responder status in a patient with a surgically placed epicardial left ventricular lead by switching to an active fixation coronary sinus lead

This report describes the reversal of a cardiac resynchronization therapy non-responder status in a patient with a surgically placed left ventricular lead by the use of a newly available active fixation coronary sinus lead.

First experience with a new active fixation coronary sinus lead

Coronary sinus (CS) lead implantation is a technically challenging procedure owing to variable vein anatomies and a high dislocation rate. Therefore, CS lead technology has undergone evolutionary changes during the last 10 years. The mode of fixation has been a passive one up to now. We want to describe our first clinical experience with the newly available active fixation lead 4195 in terms of dislocation rate and stability of thresholds compared with conventional models. From 1999 to February 2007, we implanted 403 CS leads in 368 patients. Leads were categorized into three different groups on the basis of their fixation mechanism: straight (Easytrak I and Situs OTW; n = 54), curved (Attain 4193 and 4194, Corox, Aescula, Situs ULD; n = 308), and active (Attain 4195; n = 41). Operative and follow-up data were prospectively noted and checked for significance between groups during the first 3 months after implantation. Kaplan-Meier analysis of long-term lead function was also performed. Straight and curved CS leads suffered from significantly more dislocations compared with active fixation (P < 0.001). The active fixation lead (4195) has a stable threshold over time compared with a significant rise after 24 h and thereafter in straight (62%) and curved leads (20%). However, retraction of an active fixation CS lead may be a difficult issue as outlined in two cases requiring pullback of a 4195 lead owing to phrenic nerve stimulation (one unsuccessful despite vigorous traction). The active fixation lead 4195 using retention lobes yielded stable thresholds over time and seems to be superior to conventional leads in terms of dislocation. However, extraction may be a difficult or even impossible task.