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

Adler, Stuart W.; Kirchhof, Nicole; Thompson, Amy; Foerster, L; Marquard, Kyle R.; Hine, Douglas

doi:10.1111/pace.13200

Cited by 10 publications

(12 citation statements)

References 21 publications

(66 reference statements)

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“…Although only limited data is available on the ease of extraction of the Attain Stability leads, the small side helix is designed to elongate and straighten with less than one pound of proximal pressure, thereby facilitating lead release from the fibrous capsule. In 10 sheep implanted up to 112 weeks with either the Attain Stability bipolar (n = 3) or Attain Stability Quad (n = 7) LV lead, extraction was successful in all cases with manual traction alone and without evidence of vascular trauma on pathologic examination 18 . Human data is limited to seven reported cases of extraction of the Attain Stability bipolar lead, the longest at 8 months post‐implant with successful removal in all cases 10,14,19,20 …”

Section: Discussionmentioning

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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Section: Discussionmentioning

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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“…In our experience, both QAF and BAF had a <1% that manual traction might straighten and elongate the helix so that the lead would be extracted without tissue damages. [20][21][22][23][24] Though most of these experiences are described after a quite short follow-up, nevertheless extractions in animals were reported to be successful even 2 years after implantation 20 and, notably, in humans, Barletta et al 21 have recently effectively extracted a 4-years old BAF. The QAF has been developed with the same mechanism as BAF but with four steroid-eluting pacing electrodes, thus combining the characteristics of the previous two (QPL and BAF) to overcome their limitations.…”

Section: Discussionmentioning

confidence: 99%

“…However, BAF and QAF were specifically designed with a new fixation concept, consisting of an exposed side helix, to enable a stable lead positioning, while avoiding tissue growth in the fixation mechanism for easy lead extraction. The initial experiences, both in animal models and in humans, have shown that manual traction might straighten and elongate the helix so that the lead would be extracted without tissue damages 20–24 . Though most of these experiences are described after a quite short follow‐up, nevertheless extractions in animals were reported to be successful even 2 years after implantation 20 and, notably, in humans, Barletta et al 21 have recently effectively extracted a 4‐years old BAF.…”

Section: Discussionmentioning

confidence: 99%

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

Regibus

Biffi

Infusino

et al. 2022

Cardiovasc electrophysiol

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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.

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“…Extraction was not necessary during our FU for either type of lead. But even for BipolarAS, cases of easy extractability have been reported ( 21 , 22 ).…”

Section: Discussionmentioning

confidence: 99%

Long-Term Performance Comparison of Bipolar Active vs. Quadripolar Passive Fixation Leads in Cardiac Resynchronisation Therapy

Schiedat

Bogossian

Schöne

et al. 2021

Front. Cardiovasc. Med.

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Background: Bipolar active fixation (BipolarAFL) and quadripolar passive fixation left-ventricular leads (QuadPFL) have been designed to reduce the risk of phrenic nerve stimulation (PNS), enable targeted left-ventricular pacing, and overcome problems of difficult coronary venous anatomy and lead dislodgment. This study sought to report the long-term safety and performance of a BipolarAFL, Medtronic Attain Stability 20066, compared to QuadPFL.Methods: We performed a single-operator retrospective analysis of 81 patients receiving cardiac resynchronization therapy (CRT) (36 BipolarAFL, 45 QuadPFL). Immediate implant data and electrical and clinical data during follow-up (FU) were analyzed.Results: BipolarAFL has been chosen in patients with significantly larger estimated vein diameter (at the lead tip: 7.2 ± 4.1 Fr vs. 4.1 ± 2.3 Fr, p < 0.001) without significant time difference until the final lead position was achieved (BipolarAFL: 20.9 ± 10.5 min, vs. QuadPFL: 18.9 ± 8.9 min, p = 0.35). At 12 month FU no difference in response rate to CRT was recorded between BipolarAFL and QuadPFL according to left ventricular end-systolic volume (61.1 vs. 60.0%, p = 0.82) and New York Heart Association (66.7 vs. 62.2%, p = 0.32). At median FU of 48 months (IQR: 44–54), no lead dislodgment occurred in both groups but a significantly higher proportion of PNS was recorded in QuadPFL (13 vs. 0%, p < 0.05). Electrical parameters were stable during FU in both groups without significant differences.Conclusion: BipolarAFL can be implanted with ease in challenging coronary venous anatomy, shows excellent electrical performance and no difference in clinical outcome compared to QuadPFL.

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

Abstract: 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.

Cited by 10 publications

References 21 publications

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

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

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

Long-Term Performance Comparison of Bipolar Active vs. Quadripolar Passive Fixation Leads in Cardiac Resynchronisation Therapy

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