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.

Atrial lead perforation early after device implantation-a case report and literature review.

We report three patients with screw-in lead perforation in the right atrial free wall not long after device implantation. All the patients complained of intermittent stabbing chest pain associated with deep breathing during the implantation. The "dry" epicardial puncture was utilized to avoid hemopericardium during lead extraction in the first case. The atrial electrode was repositioned in all cases and replaced by a new passive fixation lead in two patients with resolution of the pneumothorax or pericardial effusion. A literature review of 50 reported cases of atrial lead perforation was added to the findings in our case report.

Late cardiac tamponade after a helix-based active fixation leadless pacemaker implantation.

Although the late cardiac tamponade in leadless pacemaker implantation (LPI) is rare, we encountered such an incident in patient with AVEIR-VR™ system on hemodialysis and warfarinization. When LPI with active fixation system, we should aim for successful single-attempt deployment using electrical premapping to prevent cardiac tamponade including the late phase.

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.

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.

Impact of fixation mechanism and helix retraction status on right ventricular lead extraction.

Background: The impact of lead fixation mechanism on extractability is poorly characterized. Objective: We aimed to compare the technical difficulty of transvenous lead extraction (TLE) of active vs passive fixation right ventricular (RV) leads. Methods: A total of 408 patients who underwent RV TLE by a single expert electrophysiologist at Oregon Health & Science University between October 2011 and June 2022 were identified and retrospectively analyzed; 331 (81%) had active fixation RV leads and 77 (19%) had passive fixation RV leads. The active fixation cohort was further stratified into those with successfully retracted helices (n = 181) and failed helix retraction (n = 109). A numerical system (0-9) devised using 6 procedural criteria quantified a technical extraction score (TES) for each RV TLE. The TES was compared between groups. Results: Helix retraction was successful in ≥55% of active fixation TLEs. The mean TES for active-helix retracted, active-helix non-retracted, and passive fixation groups was 1.8, 3.5, and 3.7, respectively. The TES of the active-helix retracted group was significantly lower than those of the active-helix non-retracted group (adjusted P < .01) and the passive fixation group (adjusted P < .01). There was no significant difference in TES between the passive fixation and active-helix non-retracted groups in multivariate analysis (P = .18). The TLE success rate of the entire cohort was >97%, with a major complication rate of 0.5%. Conclusion: TLE of active fixation leads where helical retraction is achieved presents fewer technical challenges than does passive fixation RV lead extraction; however, if the helix cannot be retracted, active and passive TLE procedures present similar technical challenges.

The usefulness of balloon occlusive left ventricular lead delivery in combination with the quadripolar active fixation lead for a patient with complex coronary venous morphology.

Complex coronary vein morphology impedes the insertion of the left ventricular (LV) lead and reduces the effectiveness of cardiac resynchronization therapy (CRT). A 77-year-old woman underwent dual-chamber pacemaker implantation via the left subclavian approach for a complete atrioventricular block 17 years previously. She was hospitalized due to decompensated heart failure, and her cardiac rhythm completely depended on ventricular pacing at that time. Transthoracic echocardiography showed thinning of the ventricular septum in the basal region and pacing-induced dyssynchrony. She was clinically diagnosed with cardiac sarcoidosis with severe LV systolic dysfunction. She was referred for an upgrade to CRT. Given that prior contrast venography showed occlusion of the left subclavian vein, an additional LV lead was inserted through the right subclavian vein. Coronary venography showed a lateral vein that branched from the great cardiac vein with an acute angle and had multiple tortuosities in the peripheral branches. Since the LV lead placement was unsuccessful with the conventional method, we attempted the lead placement using the balloon occlusion technique (BOT). Lead delivery into the anatomical optimal lateral vein was successful by using BOT, and LV pacing from the most delayed basal region was achieved in combination with the active fixation LV lead. .

Innovative use of biotrace tempo pacemaker lead following cardiac surgery.

The Tempo® Temporary Pacing Lead is a temporary, transvenous, active fixation pacemaker lead used exclusively in structural heart and electrophysiology procedures since regulatory approval in 2016. We utilized the Tempo lead for four patients undergoing redo-robotic cardiac surgery in which surgical epicardial leads could not be placed. No failure-to-pace events were encountered and patients were able to participate in various levels of physical activity without limitation.

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.

Implantation of a dual-chamber pacemaker in a patient with dextrocardia and sick sinus syndrome: a case report.

Dextrocardia is a congenital abnormal position of the heart in which the main part of the heart is in the right chest, and the long axis of the heart points to the lower right. Cases of a combination of dextrocardia and sick sinus syndrome are rare. A 65-year-old female patient was admitted to hospital with palpitations and dizziness for 1 week. Mirror-image dextrocardia and sick sinus syndrome were diagnosed by an electrocardiogram, echocardiography, Holter monitoring, and X-rays. Finally, we successfully implanted a dual-chamber pacemaker into the patient. The patient had an uneventful recovery and was discharged when her symptoms had greatly improved 1 week later. When dextrocardia is present, using active fixation leads in the atrial and ventricular leads is easier for finding the pacing position with optimal sensing and pacing thresholds, and they reduce the incidence of falling off.

Novel lead anchor technique using an active fixation quadripolar left ventricular lead in cardiac resynchronization therapy.

In this report, we present a case of successful advancement of a LV lead into tortuous vessels. This was achieved by deep engagement of the coronary sinus with a cannulation catheter by applying the anchor technique using the Medtronic Attain Stability Quad lead.

Novel active fixation lead guided by electrical delay can improve response to cardiac resynchronization therapy in heart failure.

AIMS: Cardiac resynchronization therapy (CRT) for heart failure (HF) recently has shown optimal results by targeting electrically delayed sites in coronary sinus (CS) branches. However this purpose often cannot be reached because of unstable left ventricular (LV) lead position. In current study were assessed the long-term effects of the novel active fixation LV lead in CS, guided by electrical delay (QLV), in patients with HF due to coronary artery disease. METHODS: One hundred eighty-five consecutive patients underwent CRT with intraoperative evaluation of QLV in the target position of the LV lead. When the novel active fixation LV lead was available, 98 consecutive patients received it, composing the Fix group. They were compared with 87 patients with a conventional passive fixation lead (No Fix group). The final LV lead position was assessed by fluoroscopy. Clinical response to CRT was assessed within a period of about 3 years: patients experiencing HF rehospitalization and death due to HF were defined as non-responders. RESULTS: There were no significant differences between groups in the final position of LV lead in left anterior oblique view (Pearson χ2  = 0.12; P = 0.73). In right anterior oblique view, a basal position was reached more in the Fix group (38%) than in the No Fix group (6.5%) (Pearson χ2  = 23.095; P < 0.001). QLV was significantly greater in the Fix group (122.6 ± 33.2 ms; SE = 3.6) than in the No Fix group (97.5 ± 37.8 ms; SE = 4.9) (t = 4.17; P < 0.001). Rehospitalizations for HF were 37 in the No Fix group and 14 in the Fix group. Deaths due to HF were 49 in the No Fix group and 18 in the Fix group. Survival analysis, assessed by Cox regression, showed that the Fix group had a better outcome both for HF rehospitalizations [hazard ratio (HR) = 0.48; 95% confidence interval (CI) = 0.25-0.9; P = 0.023] and death due to HF (HR = 0.55; 95% CI = 0.31-0.97; P = 0.04) in comparison with the No Fix group. Adjustment for baseline characteristics by multivariate analysis showed that an active fixation lead in CS, as a covariate, was still significant both for HF rehospitalizations (HR 0.46; 95% CI = 0.24-0.88; P = 0.019) and for death due to HF (HR 0.5; 95% CI = 0.28-0.9; P = 0.021). CONCLUSIONS: The novel active fixation LV lead allowed to target sites with greater QLV. Often maximum QLV was documented in basal segments, were stability of conventional passive fixation leads is not enough. Patients receiving it experienced less HF rehospitalizations and less death due to HF. Active fixation lead in CS guided by QLV can improve long-term prognosis in patients with HF due to coronary artery disease undergoing to CRT.

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.