Active Fixation Coronary Sinus Research Articles

International experience with transvenous lead extractions of an active-fixation coronary sinus pacing lead

International experience with transvenous lead extractions of an active-fixation coronary sinus pacing lead

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.

B-AB02-02 OUTCOMES OF CORONARY SINUS TEAR DURING EXTRACTION OF ACTIVE FIXATION CORONARY SINUS LEADS

Active fixation coronary sinus (CS) leads provide additional support within the CS via deployable lobes or a side helix. However, adherence to the CS may lead to higher risk of extraction and CS tear during extraction. There is limited data on outcomes of CS tear during active fixation lead extraction. To assess outcomes of cardiovascular injury events and CS tear during extraction of active fixation CS leads. We searched the US Food and Drug Administration’s (FDA) Manufacturers and User Defined Experience (MAUDE) database from 8/15/2008 to 8/01/2020 for adverse events of injury or death involving the Attain StarFix lead and Attain Stability lead. Events were reviewed by 2 physicians to identify instances of cardiovascular injury during extraction. There were 25 cases of cardiovascular injury events during extraction of active fixation CS leads and all involved the Starfix lead. In 96% of cases (24/25), there was CS tear. These patients developed hypotension, pericardial effusion, or cardiac tamponade after extraction of the StarFix lead. Overall, 84% of patients (21/24) required emergency sternotomy, while 12% of patients (3/24) were successfully treated with pericardial drainage alone. Among patients who required emergency sternotomy, CS tear was successfully repaired in 86% of patients (18/21). The remaining 14% of patients (3/21) died during the surgical rescue attempt. Among the patients whom the CS was successfully repaired, 83% of patients (15/18) survived till hospital discharge. In the remaining patients, one had consumptive coagulopathy and died 45 minutes after the rescue attempt, one died at post-op day 2, and one died at post-op day 11. These findings suggest that CS tear during StarFx lead extraction often requires emergent sternotomy and repair of the CS tear. Skilled standby cardiothoracic surgery is essential when performing lead extraction of a Starfix lead. Extraction of this lead should only be attempted by highly qualified physicians in specialized centers.

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.

UK multicenter retrospective comparison of novel active versus conventional passive fixation coronary sinus leads.

A novel active fixation coronary sinus (CS) lead, Attain Stability (AS), has been released aiming to improve targeted lead positioning. Rather than being wedged into the distal vessel, it relies on a side helix for fixation. We aimed to compare implant procedure parameters and electromechanical stability of the AS lead with passive CS leads. A retrospective study involving six major UK cardiac centers. Patients who received active fixation leads were compared with passive fixation lead recipients in a 1:2 ratio. The primary outcome was total lead displacements (combined macrodisplacement/microdisplacement, defined as displacements requiring repositioning procedures, an increase in threshold ≥0.5 V or pulse width ≥0.5 ms, or a change in pacing polarity). A total of 761 patients were included (253 AS leads and 508 passive fixation leads), of which 736 had follow-up data. The primary endpoint rate was 31% (75/241) in the active and 43% (214/495) in the passive group (p = .002). Six patients (2.5%) in the active group and 14 patients (2.8%) in the passive group required CS lead repositioning procedures (p = 0.981). On multivariable analysis, active leads were associated with a reduction in lead displacements, odds ratio 0.66 (95% confidence interval: 0.46-0.95), p = .024. There were differences in favor of passive leads in procedure duration, 120 (96-149) versus 127 (105-155) min (p = .008), and fluoroscopy time, 17 (11-26) versus 18.5 (13-27) min (p = .0022). The median follow-up duration was similar (active vs. passive): 31 (17-47) versus 34 (16-71) weeks, (p = .052). AS CS leads had improved electromechanical stability compared with passive fixation leads, with only minimal increases in implant procedure and fluoroscopy times.

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

Limitations in the Extraction of Active Fixation Coronary Sinus Leads

Limitations in the Extraction of Active Fixation Coronary Sinus Leads

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.

56-53: Single Center Experience with extraction of Active Fixation Coronary Sinus Leads

56-53: Single Center Experience with extraction of Active Fixation Coronary Sinus Leads

Removal of active-fixation coronary sinus leads using a mechanical rotation extraction device.

Active fixation coronary sinus (CS) leads are widely used in cardiac resynchronization therapy (CRT). Due to their low dislodgement rates they are an attractive option for implanters. However, extraction of active fixation leads is a complex procedure that bears potential fatal risks for patients. We analyzed all patients undergoing StarFix® (Medtronic Inc., Minneapolis, MN, USA) extraction because of severe infection at our institution. Indication for extraction was severe device infection. Procedural outcomes as well as patient characteristics are reported. For removal of the leads a 9-Fr Evolution® (Cook Intravascular Inc., Leechburg, PA, USA) mechanical rotation extraction sheath was used. Between 2011 and 2014, six patients underwent extraction of StarFix® leads. One patient was female, whereas the others were males (mean age 64 ± 12 years). Implant duration was 46.5 ± 8.2 months before removal. All leads could be successfully extracted totally with the Evolution®. In one patient (16.6%) pericardial tamponade occurred immediately requiring surgical intervention. After establishment of cardiopulmonary bypass a 5-mm sharp cut in the lateral vein of the CS could be identified. It was fixed and the patient survived. On all leads, significant tissue growth between the fixation lobes could be observed. As illustrated by our cases, Attain StarFix® leads implanted years ago can be extracted with the help of a mechanical extraction sheath. However, this procedure bears potential risks and should only be performed with a cardiac surgery standby. If clinicians evaluate the implantation of Attain StarFix® leads in patients who are young or at high risk for device infection, they should be aware of these findings.

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 …

Active fixation mechanism complicates coronary sinus lead extraction and limits subsequent reimplantation targets

Implantation of cardiac resynchronization therapy (CRT) devices is technically challenging and can be limited by lead dislodgement. The Attain Starfix active fixation coronary sinus (CS) lead (model 4195, Medtronic, Minneapolis, MN, USA) was introduced to reduce the rate of lead dislodgement, but the active fixation mechanism presents additional difficulties should these leads require extraction. CS lead extraction procedures at our institution from 2003 to 2011 were reviewed. Procedural variables were compared between extraction of the Starfix lead and passive fixation CS leads. Attempts at reimplantation post Starfix lead extraction were examined. Four Starfix CS leads were extracted in four patients during this time period. The mean implant duration was 784 days (range, 392-1,029 days). The indication for extraction was infection in all four cases. Mean total procedure time was 141.5 min (range, 92-205 min). None of the fixation lobes could be retracted in one lead and only the most proximal lobes could be retracted in the remaining three leads. All four leads were removed in their entirety. The excimer laser sheath (Spectranetics Laser Sheath II, Spectranetics Corp., Colorado Springs, CO,USA) was required to remove the lead in all 4 cases (100 %) compared to 25 of 131 (19.1 %) of passive fixation CS lead extractions (mean implant duration, 659 ± 697 days) performed at our institution over the same time period (P < 0.001). In three cases, the laser sheath had to be advanced past the CS ostium to remove the Starfix lead. After extraction, fibrous material which had grown between the lobes of the fixation mechanism was noted in all four cases. No complications occurred. Transvenous CS lead reimplantation was attempted at a median of 7.5 days post extraction in all four patients. The original target branch was occluded in three patients and the main CS in one patient. Reimplantation was successful in another branch of the CS in three of four patients; one underwent minimally invasive epicardial lead placement. The Starfix active fixation CS lead presents additional procedural complexity and uniform use of excimer laser sheath compared to other CS leads. Reimplantation was not possible in the same venous branch in our experience.

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

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

060 The practice and perception of transvenous lead extraction in the UK: lessons from a nationwide survey

IntroductionThe rate of cardiac implantable electronic device (CIED) implantation in the UK has been rising consistently and this trend is likely to continue. We sought to establish the nature of...

Multicenter Experience with Transvenous Lead Extraction of Active Fixation Coronary Sinus Leads

Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding extraction of chronically implanted active fixation CS leads are limited. We performed a retrospective cohort study of patients undergoing active fixation CS lead extraction at six centers. Patient and procedural characteristics, indications for extraction, use of extraction sheath (ES) assistance, and outcomes are reported. Between January 2009 and February 2011, 12 patients underwent transvenous lead extraction (TLE) of Medtronic StarFix® lead (Medtronic Inc., Minneapolis, MN, USA). The cohort was 83% male with mean age 71 ± 14 years. Average implant duration was 14.2 ± 5.7 months (2.3-23.6). All leads but one were removed for infectious indications (67% systemic infection). At the time of explant, the fixation lobes were completely retracted in only one of the 12 cases and ES assistance was required for lead removal in all cases (58% laser, 25% cutting, 25% mechanical, and 25% femoral). The majority of cases required advancement of the sheath into the CS (75.0%) and often into a branch vessel (41.7%). One lead could not be removed transvenously and required surgical lead extraction. There were no major complications. Examination of the leads after extraction frequently revealed significant tissue growth into the fixation lobes. Although TLE of active fixation CS leads can be a safe procedure in select patients and experienced hands, powered sheaths and aggressive techniques are frequently required for successful removal despite relatively short implant durations. This raises significant concern regarding future TLE of active fixation CS leads with longer implant durations.

Active-fixation coronary sinus pacing lead extraction: A hybrid approach

Cardiac resynchronization therapy (CRT) can be considered as the standard treatment for patients suffering from heart failure (NYHA III–IV), severely reduced left ventricular (LV) function, and wide QRS complexes. Over the past years, the lead systems used to stimulate the left ventricle have evolved technically from epicardial approaches to a transvenous access accompanied by a significant reduction of procedure-related complication rates [1]. However, even today, LV dislodgement rates ranging 5–10% and the instability of thresholds over time remain the greatest challenges with transvenous LV leads in CRT. Therefore, a special LV lead utilizing active fixation (the Attain StarFix® active fixation unipolar lead, Model 4195) was developed. At the target location, three lobes at the distal end of the lead can be deployed, which compress gently against the vein wall and thereby provide enhanced fixation of the LV lead [1]. This lead is safe and highly efficacious. It affords the physician more choices in lead placement location and has a remarkably low dislodgement rate [2,3]. We describe the case of a patient implanted in 2008 with a cardiac resynchronization therapy-defibrillator (CRT-D) device and an “active-fixation” coronary sinus lead (Attain StarFix®, Model 4195 Medtronic Inc., Minneapolis, MN, USA), who underwent transvenous lead