Predictors of the right ventricular perforation caused by active-fixation pacing and defibrillator leads: A single-centre experience.

INTRODUCTION: Active-fixation leads have been associated with higher incidence of cardiac perforation. Large series specifically evaluating radiographic predictors of right ventricular (RV) lead perforation are lacking. METHODS: We conducted a retrospective observational study including 1691 consecutive patients implanted with an active fixation pacing and defibrillator lead at our institution between January 2015 and January 2021. Fourteen patients who had clinically relevant RV perforation caused by pacemaker and implantable cardioverter-defibrillator leads were included in the study. RESULTS: Univariate and multivariate analyses were used to identify predictors of RV perforation. In multivariate analysis, lead slack score (odds ratio [OR]: 3.694, 95% confidence interval [CI]: 1.066-12.807; p = .039), change in lead slack height (OR: 1.218, 95% CI: 1.011-1.467; p = .038) and width (OR: 1.253, 95% CI: 1.120-1.402; p = .001), left ventricular ejection fraction (OR: 0.995, 95% CI: 0.910-1.088; p = .032) were independent predictors of RV perforation. CONCLUSION: Fluoroscopic predictors of RV perforation associated with RV lead can be easily determined during implantation. Identification of these predictors may prevent the sequelae of RV perforation associated with active-fixation leads.

Clinical Usefulness of the Active Fixation Quadripolar Left Ventricular Lead Compared With the Passive Fixation Quadripolar Lead in Cardiac Resynchronization Therapy.

BACKGROUND: This study compared the stability of the Medtronic Attain Stability Quad (ASQ), a novel quadripolar active fixation left ventricular (LV) lead with a side helix, to that of conventional quadripolar leads with passive fixation (non-ASQ) and evaluated their LV lead performance. METHODS AND RESULTS: In all, 183 consecutive patients (69 ASQ, 114 non-ASQ) who underwent cardiac resynchronization therapy (CRT) between January 2018 and June 2021 were enrolled. Complications, including elevated pacing capture threshold (PCT) levels, phrenic nerve stimulation (PNS), and LV lead dislodgement, were analyzed during the postimplantation period until the first outpatient visit after discharge. The frequency of LV lead-related complications was significantly lower in the ASQ than non-ASQ group (14% vs. 30%, respectively; P=0.019). Specifically, LV lead dislodgement occurred only in the non-ASQ group, and elevated PCT levels were significantly lower in the ASQ group (7% vs. 23%; P=0.007). Kaplan-Meier analysis confirmed a significantly lower incidence of LV lead-related complications in the ASQ group (log-rank P=0.005). Cox multivariable regression analysis showed a significant reduction in lead-related complications associated with ASQ (hazard ratio 0.44; 95% confidence interval 0.23-0.83; P=0.011). CONCLUSIONS: The ASQ group exhibited fewer LV lead-related complications requiring reintervention and setting changes than the non-ASQ group. Thus, the ASQ may be a favorable choice for CRT device implantation.

Temporary-permanent pacemakers are associated with better clinical and safety outcomes compared to balloon-tipped temporary pacemakers.

BACKGROUND: Balloon Tipped Temporary Pacemakers (BTTP) are the most used temporary pacemakers; however, they are associated with a risk of dislodgement and thromboembolism. Recently, Temporary Permanent Pacemakers (TPPM) have been increasingly used. Evidence of outcomes with TPPM compared to BTTP remains scarce. METHODS: Retrospective, chart review study evaluating all patients who underwent temporary pacemaker placement between 2014 and 2022 (N = 126) in the cardiac catheterization laboratory (CCL) at a level 1 trauma center. Primary outcome of this study is to evaluate the safety profile of TPPM versus BTTP. Secondary objectives include patient ambulation and healthcare utilization in patients with temporary pacemakers. RESULTS: Both groups had similar baseline characteristics distribution including gender, race, and age at temporary pacemaker insertion (p > .05). Subclavian vein was the most common site of access for the TPPM cohort (89.0%) versus the femoral vein in the BTTP group (65.1%). Ambulation was only possible in the TPPM group (55.6%, p < .001). Lead dislodgement, venous thromboembolism, local hematoma, and access site infections were less frequently encountered in the TPPM group (OR = 0.23 [95% CI (0.10-0.67), p < .001]). Within the subgroup of patients with TPPM, 36.6% of the patients were monitored outside the ICU setting. There was no significant difference in the pacemaker-related adverse events among patients with TPPM based on their in-hospital setting. CONCLUSION: TPPM is associated with a more favorable safety profile compared to BTTP. They are also associated with earlier patient ambulation and reduced healthcare utilization.

An active fixation quadripolar left ventricular lead for cardiac resynchronization therapy with reduced postoperative complication rates.

BACKGROUND: The rate of left ventricular (LV) lead displacement after cardiac resynchronization therapy (CRT) remains high despite improvements in lead technology. In 2017, a novel quadripolar lead with active fixation technology became available in the UK. METHODS: This was a retrospective, observational study analyzing device complications in 476 consecutive patients undergoing successful first-time implantation of a CRT device at a tertiary center from 2017 to 2020. RESULTS: Both active (n = 135) and passive fixation (n = 341) quadripolar leads had similar success rates for implantation (99.3% vs. 98.8%, p = 1.00), although the pacing threshold (0.89 [0.60-1.25] vs. 1.00 [0.70-1.60] V, p = .01) and lead impedance (632 [552-794] vs. 730 [636-862] Ohms, p < .0001) were significantly lower for the active fixation lead. Patients receiving an active fixation lead had a reduced incidence of lead displacement at 6 months (0.74% vs. 4.69%, p = .036). There was no significant difference in the rate of right atrial (RA) and right ventricular (RV) lead displacement between the two groups (RA: 1.48% vs. 1.17%, p = .68; RV: 2.22% vs. 1.76%, p = .72). Reprogramming the LV lead after displacement was unsuccessful in most cases (successful reprogramming: Active fix = 0/1, Passive fix = 1/16) therefore nearly all patients required a repeat procedure. As a result, the rate of intervention within 6 months for lead displacement was significantly lower when patients were implanted with the active fixation lead (0.74% vs. 4.40%, p = .049). CONCLUSION: The novel active fixation lead in our study has a lower incidence of lead displacement and re-intervention compared to conventional quadripolar leads for CRT.

Long-term follow-up of patients with a quadripolar active fixation left ventricular lead: An Italian multicenter experience.

INTRODUCTION: Left ventricular (LV) lead optimal positioning is one of the most important determinants of cardiac resynchronization therapy (CRT) success. LV quadripolar active fixation (QAF) leads have been designed to ensure stable LV pacing in the target area and reduce the likelihood of phrenic nerve stimulation (PNS). The aim of this analysis is to compare performances, safety, and clinical outcomes of QAF with those of quadripolar passive fixation leads (QPL) and bipolar active fixation (BAF) leads in a real-world cohort of CRT patients. METHODS AND RESULTS: This retrospective analysis compared the procedure and follow-up data of 117 QAF included in the One Hospital ClinicalService project from nine Italian hospitals with two historical cohorts of 261 BAF and 124 QPL. QAF enabled basal pacing more frequently than QPL (24.1% vs. 6.5%, p < .001) but not differently from BAF (p = .981). At implant, mean QAF LV myocardial threshold (LVMT) was 1.21 ± 0.8 V at 0.4 ms, not different from that of BAF (p = .346) and QPL (p = .333). At a median follow-up of 22 months, LVMT was 1.37 ± 0.90 V (p = .036 vs. implant). Acute LV lead dislodgment occurrence was low in all cohorts: 1 (0.9%) in QAF, 4 in BAF (1.5%), and none (0.0%) in QPL. During follow-up, total LV-related complication rate was lower in QAF (0.5/100 patient-years) than in BAF (4.2/100 patient-years, p = .014) and QPL (3.6/100 patient-years, p = .055). QAF, BAF, and QPL annual rate of heart failure hospitalization were respectively 6.1/100 patient-years, 2.5/100 patient-years (p = .081), and 3.6/100 patient-years (p = .346). CRT responders' rate in QAF was 69.9%, with no difference in comparison to BAF (p = .998) and QPL (p = .509). During follow-up, mean left ventricular ejection fraction (LVEF) of QAF increased from 31.8 ± 10.1% to 40.3 ± 10.7% (p < .001). The average degree of echocardiographic response (ΔLVEF) did not differ between QAF and other cohorts; however, LVEF CRT responder's distribution of QAF differs from those of BAF (p = .003) and QPL (p = .022), due to a higher percentage of super-responders. CONCLUSIONS: QAF with short interelectrode spacing resulted in non-inferior clinical outcomes and CRT responders' rate in comparison to BAF and QPL, while reducing complication rate during follow-up and increasing the possibilities of electronic repositioning to manage PNS or to optimize resynchronization therapy.

Outcomes of temporary pacing using active fixation leads and externalized permanent pacemakers in patients with cardiovascular implantable electronic device infection and pacemaker dependency.

INTRODUCTION: The incidence of cardiac implantable electronic device (CIED) infections is increasing. Complete device and lead removal are recommended for all patients with definite CIED system infection. In patients with pacemaker dependency, temporary pacing before reimplantation is necessary. In this study, temporary pacing using active fixation leads (TPAFL) was evaluated. METHODS: We reviewed data from consecutive patients implanted with TPAFL after transvenous lead extraction at our center between November 2014 and October 2020. RESULTS: TPAFL were placed in 334 patients. The mean age was 64.5 ± 16.4 years and 76.3% were males. Two hundred and forty (72%) were treated due to local pocket infection and 94 (28%) systemic infection. The indication for temporary pacing was sick sinus syndrome in 135 (40.4%) patients and complete or high-grade atrioventricular (AV) block in 199 (59.6%) patients. The most common access site for lead implantation was the ipsilateral subclavian or axillary vein (78.9%). A new permanent CIED was reimplanted at 10.3 ± 9.2 days (median 10, range: 2-70) after implantation of the temporary pacing. There were five (1.5%) adverse events related to the temporary pacing during hospitalization. The median follow-up duration was 23.1 months (interquartile range [IQR], 7.2-43.4 months). Only one patient (0.3%) developed recurrent CIED infection. CONCLUSION: TPAFL is safe and effective in pacemaker-dependent patients after infected CIED removal. The rate of temporary pacing-related complications, including lead dislodgment and reinfection of CIED is relatively low.

Clinical outcome of cardiac resynchronization therapy in patients randomized to an active fixation bipolar left ventricular lead versus a passive quadripolar lead.

Objectives: To compare the clinical outcome of cardiac resynchronization therapy (CRT) in patients receiving a bipolar left ventricular (LV) lead with a side helix for active fixation to the outcome in patients receiving a quadripolar passive fixation LV lead.Design: Sixty-two patients (mean age 72 ± 11 years) were blindly and randomly assigned to the active fixation bipolar lead group (n = 31) or to the quadripolar lead group (n= 31). The LV leads were targeted to the basal LV segment in a vein concordant to the LV segment with the latest mechanical contraction chosen on the basis of preoperative radial strain (RS) echocardiography.Results: At the 6-month follow-up (FU), the reduction in LV end-systolic volume and LV reverse remodelling responder rate, defined as LV end-systolic volume reduction >15%, was 77% in the active fixation group and 83% in the quadripolar group, which was not significantly different. At the 12-month FU, the LV ejection fraction (LVEF) did not differ between the groups. There were no significant differences between the two groups in changes in New York Heart Association (NYHA) functional class or Minnesota Living with Heart Failure Questionnaire score. The occurrence of phrenic nerve stimulation (PNS) was 19% in the active fixation group versus 10% in the quadripolar group (p=.30), and all cases were resolved by reprogramming the device. All patients were alive at the 12-month FU. There was no device infection.Conclusions: There were no significant differences between the active fixation group of patients and the quadripolar group of patients concerning improvement in echocardiographic parameters or clinical symptoms.ClinicalTrials.gov number, NCT04632472.

[Progressive cardiac tamponade and right ventricular free wall perforation as complications after dual-chamber pacemaker implantation - a case report]. / Perforacja wolnej sciany prawej komory i postepujaca tamponada serca jako powiklanie po implantacji dwujamowego ukladu stymulujacego - opis przypadku.

In recent years the number of complications related to implantation of cardiac stimulating systems is increasing. Life-threatening myocardial perforation leading to cardiac tamponade is one of the rarest complications. In that case it is necessary to take the immediate lifesaving procedures. A CASE REPORT: 61-year-old woman ended up in the cardiac surgery department with progressive cardiac tamponade and cardiogenic shock symptoms. Three weeks earlier due to the tachycardia-bradycardia syndrome with second-degree atrioventricular block diagnosis, the cardiac stimulating system was implanted into the heart at the cardiology department. Two days after the discharge from hospital the patient appeared in the emergency department with non-specific chest symptoms, which disappeared after analgesic drugs. After another two weeks the patient returned to the emergency department in general poor condition. Echocardiographic examination showed fluid in both pleural cavities, a dense layer around heart and fluid out wards from the layer in the pericardial space. Furthermore, CT scan showed unobvious shape crossing the heart muscle. Firstly, the patient was admitted to the cardiology department and next transferred to the cardio surgery where on account of deteriorating condition was made a decision urgent sternotomy and revision pericardial sac. Intraoperatively were found perforation of right ventricular free wall caused by stimulation electrode and hole communicating pericardial space with left pleural cavity. The operation went well, without any complications. The patient was discharged from hospital 12 days after surgery. CONCLUSIONS: In the case of suspected complications related to the implantation of electrostimulation equipment, it is necessary to perform appropriate diagnostics and implement urgent procedures, including surgery.

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

BACKGROUND: 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. METHODS: 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). RESULTS: 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). CONCLUSION: AS CS leads had improved electromechanical stability compared with passive fixation leads, with only minimal increases in implant procedure and fluoroscopy times.

Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results.

INTRODUCTION: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. METHODS: Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence. RESULTS: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. CONCLUSIONS: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.

His bundle pacing using a simple stylet and a standard active fixation electrode.

Conventionally, His bundle pacing (HBP) is achieved using specially designed pacing leads and delivery sheaths. This paper describes the feasibility of permanent HBP with a pre-shaped simple stylet and a standard active-fixation electrode, through axillary vein access, without using dedicated delivery tools. This method may be a feasible and safe alternative to the only commercially available system.

Transvenous dual-chamber pacemaker implantation in patients with persistent left superior vena cava.

BACKGROUND: Persistent left superior vena cava (PLSVC) is a rare congenital vascular anomaly. Permanent pacemaker implantation (PPI) in patients with PLSVC can be challenging because of the venous anomalies. We reported a case series of patients with PLSVC who underwent PPI with double active fixation leads. METHODS: From January 2012 to July 2016, 9 patients (three male and six females, mean age 68 ± 11 years) with PLSVC who received a dual-chamber pacemaker with double active fixation leads were enrolled retrospectively in this observational study. The indications for pacemaker implantation were symptomatic third-degree atrioventricular block in one and sick sinus syndrome in eight patients. RESULTS: PPI were implanted successfully in all 9 patients. Successful positioning of the ventricular leads at the right ventricular outflow tract (RVOT) septum with a "C" shaped stylet was achieved in 7 patients (77.8%). In the remaining two cases, the ventricular leads were placed in the right ventricular apex and the inferior free wall of the sub-tricuspid annulus. The atrial leads were placed at the lateral wall of the right atrium in all patients. Procedure time and fluoroscopy time were 85.3 ± 11.3 min and 4.5 ± 1.1 min respectively. During a mean follow-up of 4 years, no complications were observed and pacing parameters did not change significantly. CONCLUSION: PPI through PLSVC may be technically feasible, safe, and effective. Double active fixation leads may be standard for patients with PLSVC and most of the ventricular leads could be placed at the RVOT septum.

Incidence and predictors of clinically relevant cardiac perforation associated with systematic implantation of active-fixation pacing and defibrillation leads: a single-centre experience with over 3800 implanted leads.

AIMS: Active-fixation leads have been associated with higher incidence of cardiac perforation. Large series specifically evaluating this complication are lacking. We sought to evaluate the incidence and predictors of clinically relevant cardiac perforation in a consecutive series of patients implanted with active-fixation pacing and defibrillation leads. METHODS AND RESULTS: We conducted a retrospective observational study including all consecutive patients implanted with an active-fixation pacing/defibrillation lead at our institution from July 2008 to July 2015. The incidence of clinically relevant cardiac perforation and cardiac tamponade was evaluated. Univariate and multivariate analyses were used to identify predictors of cardiac perforation. Acute and long-term management of these patients was also investigated. A total of 3822 active-fixation pacing (n = 3035) and defibrillation (n = 787) leads were implanted in 2200 patients. Seventeen patients (0.8%) had clinically relevant cardiac perforation (13 acute and 4 subacute perforations), and 13 (0.5%) had cardiac tamponade resolved with pericardiocentesis. None of the patients with cardiac perforation required surgical treatment. In multivariate analysis, an age >80 years (OR 3.84, 95% CI 1.14-12.87, P = 0.029), female sex (OR 3.14, 95% CI 1.07-9.22, P = 0.037), and an apical position of the right ventricular lead (OR 3.37, 95% CI 1.17-9.67, P = 0.024) were independent predictors of cardiac perforation. CONCLUSIONS: Implantation of active-fixation leads is associated with a low incidence of clinically relevant cardiac perforation. Older and female patients have a higher risk of perforation as well as those patients receiving the ventricular lead in an apical position.

Two-year extractability of novel left ventricular, active fixation leads in the sheep model.

BACKGROUND: A cardiac lead with a side helix for active fixation to the coronary vein wall (Attain Stability® , Model 20066, Medtronic, Minneapolis, MN, USA) recently received CE Mark. The lead is designed to improve left ventricular (LV) placement and reduce dislodgement rates. The extractability of this active fixation LV lead has not been studied extensively. METHODS: Seventeen sheep were implanted with either an LV lead with a side helix (Model 20066, Model 20096, Medtronic) or a unipolar LV lead (Model 4193, Medtronic) as a control. Leads were extracted at approximately 26, 52, or 118 weeks. Standard extraction methodology was employed with quantitative traction up to 907 g (2 lbs.) using a locking stylet. Gross pathology and histology of the heart with particular attention to the lead tracts were performed. RESULTS: All leads were successfully removed in their entirety and required significantly less than 1 kg of traction force. The side helix disengaged from the vein as designed and resulted in no complications. No cardiac tissue was observed on any extracted lead. Gross pathology and histology were devoid of any helix-induced lesions in the vascular structures. The epicardium over the side helix was normal and the fibrotic reaction around the helix was not significantly different from that around the nonhelix portions of the study leads or the control lead. CONCLUSION: Extraction of the side helix, active fixation LV lead from the coronary veins in the sheep model is safe, without procedural complexity, and free of complications after long-term LV lead implant duration.

Active fixation of a thin transvenous left-ventricular lead by a side helix facilitates targeted and stable placement in cardiac resynchronization therapy.

AIMS: Suboptimal placement, phrenic nerve stimulation, and dislodgements of left-ventricular (LV) leads are main challenges in cardiac resynchronization therapy. We investigated the handling, performance, safety, and stability for a novel 4Fr LV lead with a small side helix located proximal to the ring electrode for active fixation of the LV lead. METHODS AND RESULTS: The novel LV lead was successfully implanted in 103 of 106 patients. Patients with dislodged LV leads and with demanding coronary vein anatomies were included. The lead body was rotated clockwise to engage the active fixation side helix in the vein wall. The stimulating electrode was located in basal LV segment and middle LV segment in 54 and 46% of the patients, respectively. The lead was targeted to a vein concordant to the LV segment with latest mechanical activation. Concordant LV lead placement was achieved in 73% of the patients and in adjacent segment in 24%. The average pacing capture threshold (PCT) at implantation was 1.04 ± 0.6 V (n = 103) and at an average follow-up at 7 months, the PCT remained low and no dislodgements have been observed. During follow-up, four leads have been explanted without complications. CONCLUSION: Active fixation of this 4Fr LV lead by using a side helix, offers flexibility to place the lead precisely in targeted vein segments over a wide range of vein anatomies. The average LV pacing threshold was low at implantation and follow-ups. The lead seems to be extractable and no late dislodgements have been observed.

The novel active fixation coronary sinus lead: efficacy and safety of transvenous extraction procedure.

AIMS: Benefits of cardiac resynchronization therapy (CRT) are well known for heart failure; however, some patients might experience complications related to the coronary sinus (CS) lead (high pacing threshold, phrenic nerve stimulation, and dislodgment) with unfavourable impact on quality of life, costs, and management. Lead stability is one of the most common unmet needs for CRT procedures. METHODS AND RESULTS: Recently, new model Medtronic 20066 Attain Stability(®) (Maastricht, The Netherlands) active fixation LV lead has been released, to overcome this issue. The lead has a small side helix of 0.20 mm (0.008 in.) that allows for secure placement of the lead within the vein at the desired location. We report our first experience with the extraction of this novel active fixation left ventricular lead. CONCLUSION: In our case, to our knowledge the first reported in humans, the extraction of this new model of active fixation lead was proved to be a safe and effective procedure at 8 months after implantation. Indeed, under angiographic and fluoroscopic check, there was no documented dissection or damage to the CS during and after removal of the lead. The rotation manoeuvre was effective when combined with moderate traction of the lead itself.

Early experience with attain stability, an activefixation LV lead: virtues and pitfalls.

BACKGROUND: Appropriate left ventricle (LV) lead placement is integral to successful cardiac resynchronization therapy (CRT). Lead dislodgement and phrenic nerve stimulation (PNS) are major obstacles. A recent trial of an active fixation LV lead (Attain Stability 20066, Medtronic Inc., Tilburg, the Netherlands) has shown promising results. We share our initial experience with this novel active fixation LV lead. METHODS: A Medtronic active fixation lead 20066 was used in eight consecutive patients for CRT. An optimal site was chosen and recommended maneuvers were applied for lead fixation. Push and pull maneuvers were used to test stability. RESULTS: There were two initial dislodgements after which we used a transvalvular insertion (TVI) tool that was used in the hemostatic valve during rotation of the lead so that the torque was easily transmitted to the tip. It also allowed better tactile feedback during push-pull tests. There were no further dislodgements in the subsequent six patients. However, in one patient the lead could not be unscrewed due to the tip getting wedged at a distal smaller vein. Repositioning of the LV lead was done in three patients due to PNS or pacing issues. The median time for LV lead placement was 16.5 minutes (interquartile range 9-25 minutes). CONCLUSION: The Medtronic Attain Stability 20066 active fixation LV lead can potentially be implanted at any pacing site avoiding PNS and providing better stability. The learning curve is short and additional tricks can be learnt to improve success. Use of TVI while the lead is rotated is beneficial.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Prediction of midterm performance of active-fixation leads using current of injury.

BACKGROUND: There are only limited prospective data on the clinical relevance of current of injury (COI) as a predictor of the midterm performance of active-fixation leads. This study sought to investigate whether it is possible to predict the midterm performance of active-fixation leads using COI recorded at the time of implantation. METHODS AND RESULTS: One hundred fifty patients (78 men; mean age, 63 ± 19 years) who received active-fixation pacing (n = 201) and defibrillator (n = 51) leads were studied. COI was measured from the intracardiac bipolar electrogram recorded at the time of lead implantation. The study outcome was good lead performance at 6 months, defined as P wave ≥ 1.5 mV, threshold <1.5 V for atrial lead, R-wave ≥ 5 mV, and threshold <1 V for ventricular lead. A total of 102 active-fixation atrial and 150 ventricular leads were implanted. During a 6-month follow-up, invasive intervention was required for seven atrial and seven ventricular leads. In multivariate analysis, COI was the only independent predictor of good outcome for the active-fixation atrial (odds ratio [OR]: 5.67, 95% confidence interval [CI]: 2.18-14.76, P = 0.001) and ventricular leads (OR: 3.99, 95% CI: 1.08-21.26, P = 0.002). Receiver-operating characteristic analysis identified ST-segment elevation ≥2.0 mV for the atrial leads (sensitivity, 75%; specificity, 89%) and ≥10.0 mV for the ventricular leads (sensitivity, 70%; specificity, 87%) as optimal cutoffs for good midterm performance. CONCLUSIONS: Midterm performance of active-fixation leads is predictable using COI recorded at the time of lead implantation. A ST-segment elevation ≥2.0 mV in the atrial leads and ≥10.0 mV in the ventricular leads are recommended to improve the lead performance at 6 months.

Cardiac tamponade due to right coronary artery perforation following pacemaker implantation: a case report.

Background: Cardiac tamponade due to perforation of a cardiac chamber is a rare complication occurring in only 0.3% of patients undergoing permanent pacemaker (PM) implantation. Notably, perforation of the right coronary artery (RCA) following permanent PM implantation has only been reported twice in the literature. We report a rare case of RCA perforation leading to life-threatening cardiac tamponade with symptom onset 4 days after PM implantation. Case summary: A 75-year-old woman underwent permanent PM implantation without any difficulties in placing pacemaker leads and with good thresholds. Four days later, the patient was readmitted in a state of shock due to cardiac tamponade. A blood gas analysis on the bloody pericardial effusion raised suspicion of ongoing arterial bleeding. A CT scan ruled out aortic dissection; instead, the source of bleeding was identified as a perforation in the RCA, which was managed surgically. Discussion: This case highlights the necessity of coronary artery perforation being among the differential diagnoses of cardiac tamponade after PM implantation, and it stresses the usefulness of performing a blood gas analysis on the bloody pericardial effusion.