Long‐term electrical performance of Attain Performa quadripolar left ventricular leads with all steroid‐eluting electrodes: Results from a large worldwide clinical trial

Lin, Albert; Biffi, Mauro; Exner, Derek V.; Johnson, W. Ben; Gras, Daniel; Hussin, Azlan; Yang, Zhongping; Hine, Douglas; Li, Shelby; Crossley, George H.

doi:10.1111/pace.13389

Cited by 6 publications

(6 citation statements)

References 20 publications

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“…An additional finding was that E3 and E4 electrodes had higher thresholds, and this was consistent for all lead models. Interestingly, the same findings were reported in leads with different designs from other manufacturers, and possibly stem from less intimate contact with the myocardium of these electrodes. Capture thresholds are also likely to be affected by the anatomy of the coronary sinus tributary (vessel diameter, tortuosity, etc).…”

Section: Discussionsupporting

confidence: 75%

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Effect of lead design and pacing vector on electrical parameters of quadripolar coronary sinus leads: The RALLY‐X4 study

Burri

Schrage

Morani

et al. 2019

Pacing Clinical Electrophis

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Background: Various lead designs have been developed to accommodate different coronary sinus anatomies. Our objectives were to compare electrical parameters of straight and spiral left ventricular leads, to evaluate capture thresholds and impedances using different pacing vectors, and to study evolution of thresholds over time. Methods:The RALLY-X4 study enrolled patients implanted with a lead from the Acuity X4 family (straight, spiral short, or spiral long). Electrical parameters (including capture thresholds from all 17 vectors) were measured at baseline and follow-up. Results: Data from 795 patients who were successfully implanted were analyzed. Straight and spiral leads had similar proportions of patients with thresholds <2.5 V/0.4 ms using the distal electrode (61-65% of patients) or from at least one of the proximal (E2-E4) electrodes (81-83% of patients). Unipolar vectors had significantly lower thresholds and impedances than bipolar vectors, with similar measurements compared to extended bipolar configurations. Capture thresholds increased with more proximal electrodes for all leads. Over a mean follow-up of 1 year, a slight decrease in capture thresholds was observed. Conclusion: Straight and spiral quadripolar leads allow to obtain clinically acceptable capture thresholds from at least one of the proximal electrodes in >80% of patients. Pacing vectors significantly affect electrical parameters, with higher thresholds in more proximal electrodes and lower thresholds with unipolar and extended bipolar configurations. Capture thresholds slightly decreased over a mean follow-up of 1 year. K E Y W O R D S capture threshold, Cardiac resynchronization therapy, impedance, pacing leads 1018

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Section: Discussionsupporting

confidence: 75%

“…Along with the study by Lin et al, our study provides the longest available follow‐up data of electrical parameters for LV leads, with an average follow‐up of 1 year. Overall, there was a slight reduction in capture thresholds at follow‐up, which was more marked for the two most proximal electrodes of spiral leads.…”

Section: Discussionmentioning

confidence: 99%

Effect of lead design and pacing vector on electrical parameters of quadripolar coronary sinus leads: The RALLY‐X4 study

Burri

Schrage

Morani

et al. 2019

Pacing Clinical Electrophis

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“…Currently available LV quadripolar pacing leads have a variety of shapes and electrode spacing; however, all are passively fixated by advancing the lead tip distally within the target branch and dislodgements are the most common lead‐related adverse event reported 6 . In addition, PCTs are significantly higher and often unacceptable at basal vectors for these passively fixated quadripolar leads due to larger vessel diameter in this region and poor tissue‐electrode contact although steroid elution on these proximal electrodes may mitigate this problem 7,8 …”

Section: Introductionmentioning

confidence: 99%

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

Jackson

Færestrand

Philippon

et al. 2020

Cardiovasc electrophysiol

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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. K E Y W O R D S active fixation, cardiac resynchronization therapy, lead dislodgement, LV lead, quadripolar lead 1148 | JACKSON ET AL.

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“…This notwithstanding, the safety and efficacy results refer exclusively to the use of unipolar leads, which no longer represent state-of-the-art LV pacing through the coronary sinus, given that the last 3 years have seen the development of quadripolar leads that facilitate positioning with ideal stimulation in a location far from the phrenic nerve. 36 , 37…”

Section: Discussionmentioning

confidence: 99%

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

Crevelari¹,

Silva²,

Albertini³

et al. 2018

Arquivos Brasileiros De Cardiologia

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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.

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Long‐term electrical performance of Attain Performa quadripolar left ventricular leads with all steroid‐eluting electrodes: Results from a large worldwide clinical trial

Cited by 6 publications

References 20 publications

Effect of lead design and pacing vector on electrical parameters of quadripolar coronary sinus leads: The RALLY‐X4 study

Effect of lead design and pacing vector on electrical parameters of quadripolar coronary sinus leads: The RALLY‐X4 study

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

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

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