Safety and effectiveness of a 6‐French MRI conditional pacemaker lead: The INGEVITY<sup>TM</sup> clinical investigation study results

Nielsen, Jens Cosedis; Giudici, Michael; Viu, Jose Maria Tolasana; Chew, E. W.; Sommerijns, Elke; Wold, Nicholas; Evert, Linda; Love, Charles J.; Steín, Kenneth M.; Hedrich, Olaf

doi:10.1111/pace.13159

Cited by 3 publications

(4 citation statements)

References 24 publications

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“…These leads incorporate design aspects for MRI conditional safety. The inner coil of the MRI lead was modified to have a higher inductance to prevent heating during MRI scanning, which was achieved through the unifilar design of the inner coils of the INGEVITY leads [ 13 , 15 , 16 ]. However, because torque transfer decreased in a unifilar inner coil, the INGEVITY+ leads were upgraded to a trifilar coil design.…”

Section: Methodsmentioning

confidence: 99%

Performance and Physician Experience of INGEVITY+ Active Fixation Leads: Prospective INGEVITY+ Lead Clinical Study in Korea

Joung,

Bae,

et al. 2024

Cardiology Research and Practice

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Background. Boston Scientific INGEVITY+ pacing lead (Boston Scientific, Marlborough, MA, USA) has been upgraded to INGEVITY. The performance of the INGEVITY+ pacing lead has not yet been reported. This study aimed to evaluate the short- and long-term safety, effectiveness, and handling experience of INGEVITY+ leads. Methods. Consecutive patients were included from 9 institutions in Korea, where 400 leads (200 right ventricular active fixation leads and 200 right atrial active fixation leads) were implanted or attempted in 200 subjects. Results. During the implantation, only one patient required a lead change because of lead screw failure. The handling questionnaires of the lead received very positive feedback with 88% of operators agreeing that it is easy for leads to pass through small vessels or vessels with multiple leads. At the 3-month follow-up, 95.7% of RA leads and 99.5% of RV leads had pacing thresholds less than 1.5 V. A total of 92.4% of atrial leads had amplitudes greater than 1.5 mV, and 96.5% of ventricular leads had sensing amplitudes greater than 5 mV at 3 months. A total of 99.8% had impedances between 300 and 1,300 ohms. The lead-related complication-free rate for all leads during follow-up was 100%, and the overall rates of lead dislodgment, perforation, and pericardial effusion were all 0.0%. Conclusions. The INGEVITY+ pacing lead exhibited exceptional clinical performance, with a high complication-free rate throughout the 3-month follow-up period. In addition, the lead displayed excellent electrical characteristics, and the lead-handling experience was reported to be very good.

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Section: Methodsmentioning

confidence: 99%

Performance and Physician Experience of INGEVITY+ Active Fixation Leads: Prospective INGEVITY+ Lead Clinical Study in Korea

Joung,

Bae,

et al. 2024

Cardiology Research and Practice

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“…The unique construction of the INGEVITY lead has been previously described 4 . Both the inner and outer conductor coils are a single filar of MP35N wire.…”

Section: Introductionmentioning

confidence: 99%

“…The unique construction of the INGEVITY lead has been previously described. 4 Both the inner and outer conductor coils are a single filar of MP35N wire. This design minimizes the electrical coupling during an MRI in order to reduce potential heating of the tip; however it also reduces the axial strength of the lead when used as a rail for extraction.…”

Section: Introductionmentioning

confidence: 99%

Strategies to increase the INGEVITY lead strength during lead extraction procedures based on laboratory bench testing

Vatterott

Kock

Hammill

et al. 2021

Pacing Clinical Electrophis

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Background The INGEVITY lead (Boston Scientific, St Paul, MN, USA) has excellent clinical performance. However, its single filar design results in decreased lead tensile strength and a possible challenging extraction. This study's goal is to evaluate techniques for extracting the INGEVITY lead. Methods Two‐ and three‐dimensional models were created to simulate lead extraction from a right atrial appendage lead implant with a left subclavian approach and lead/fibrosis attachment sites. Standard and unique lead extraction preparation strategies were evaluated. Traction forces were measured from a superior approach alone or in combination with a femoral approach. Results For lead extraction via the superior approach, leaving the terminal on the lead was the only factor influencing maximum tolerated load (p‐value = .0007). Scar attachment provided greater lead tensile strength by transferring traction loading forces to the polyurethane outer insulation but dependent on insulation integrity. The strongest extraction rail was seen with a simulated femoral snaring of a locking stylet within the INGEVITY lead. Deployed screw retraction was most successful by rotating a Philips LLD#2 stylet (Philips Healthcare, Amsterdam, Netherlands) within the lead. Conclusion Results from in vitro simulations of INGEVITY lead extraction from an atrial location found the lead has low maximum tensile strength resulting in a poor extraction rail with common extraction tools and methods. However, the strength of the INGEVITY Lead extraction rail can be significantly increased by leaving the lead terminal intact and femoral snaring of the locking stylet within the lead. Such techniques may improve extraction of the INGEVITY lead.

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“…he Ingevity family of magnetic resonance imaging provisional pacemaker leads is manufactured by the Boston Scientific Corporation (Marlborough, MA). [1][2][3] Starting in 2017, there were reports of unreliability in the helix deployment mechanism of the Ingevity magnetic resonance imaging lead. 4 This led to lead replacements during implantation procedures.…”

mentioning

confidence: 99%

Spontaneous Helix Retraction of the Ingevity+ Pacemaker Lead: A Single-Center Experience

Monfredi

Heard

Zimmerman

et al. 2021

Circ: Arrhythmia and Electrophysiology

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Safety and effectiveness of a 6‐French MRI conditional pacemaker lead: The INGEVITY^TM clinical investigation study results

Abstract: The clinical performance of the INGEVITY lead demonstrated a high lead-related complication-free rate over 12 months of follow-up and excellent electrical characteristics.

Cited by 3 publications

References 24 publications

Performance and Physician Experience of INGEVITY+ Active Fixation Leads: Prospective INGEVITY+ Lead Clinical Study in Korea

Performance and Physician Experience of INGEVITY+ Active Fixation Leads: Prospective INGEVITY+ Lead Clinical Study in Korea

Strategies to increase the INGEVITY lead strength during lead extraction procedures based on laboratory bench testing

Spontaneous Helix Retraction of the Ingevity+ Pacemaker Lead: A Single-Center Experience

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Safety and effectiveness of a 6‐French MRI conditional pacemaker lead: The INGEVITYTM clinical investigation study results

Abstract: The clinical performance of the INGEVITY lead demonstrated a high lead-related complication-free rate over 12 months of follow-up and excellent electrical characteristics.

Cited by 3 publications

References 24 publications

Performance and Physician Experience of INGEVITY+ Active Fixation Leads: Prospective INGEVITY+ Lead Clinical Study in Korea

Performance and Physician Experience of INGEVITY+ Active Fixation Leads: Prospective INGEVITY+ Lead Clinical Study in Korea

Strategies to increase the INGEVITY lead strength during lead extraction procedures based on laboratory bench testing

Spontaneous Helix Retraction of the Ingevity+ Pacemaker Lead: A Single-Center Experience

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Product

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Safety and effectiveness of a 6‐French MRI conditional pacemaker lead: The INGEVITY^TM clinical investigation study results