Surreal illustration of a heart intertwined with pacemaker leads, symbolizing heart health and technology.

Heart Health SOS: Are Your Pacemaker Leads Putting You at Risk?

Avery Sinclair in Health & Wellness September 2025 • 4 min read.

"New research sheds light on the long-term performance of pacing leads, revealing potential risks and what you need to know to protect your heart."

For many, pacemakers are a lifeline, providing essential support to regulate heart rhythms and maintain overall well-being. These small devices rely on leads, thin wires that deliver electrical impulses to the heart. While pacemakers have greatly improved in design and function, recent research suggests that certain types of pacing leads may come with unforeseen risks, potentially leading to malfunctions and the need for further intervention.

A new study published in Heart Rhythm, the official journal of the Heart Rhythm Society, delves into the long-term performance of a specific family of pacing leads, revealing important insights that could impact patient care and device selection. Understanding these findings is crucial for anyone with a pacemaker, as well as their families and caregivers.

This article breaks down the key findings of the study, explains the potential risks associated with certain pacing leads, and provides actionable information to help you advocate for your heart health. We'll explore the types of leads involved, the observed malfunction rates, and what this means for the future of pacemaker technology.

The Tendril Lead Study: Unveiling the Risks

Surreal illustration of a heart intertwined with pacemaker leads, symbolizing heart health and technology.

The Heart Rhythm study focused on the long-term performance of the Abbott/St. Jude Tendril pacing lead family, analyzing data from nearly 10,000 leads implanted over a decade at a single center. The research team sought to compare the Tendril leads to other commonly used pacing leads, including Medtronic CapSure Fix Novus and Boston Scientific Fineline II Sterox Pacing EZ Leads. The primary goal was to determine the incidence of lead malfunction, assessed through rigorous Kaplan-Meier analysis, a statistical method used to estimate the probability of an event over time.

The study revealed a concerning trend: Tendril leads exhibited a significantly higher rate of malfunction compared to non-Tendril leads. Over a five-year period, the malfunction rate for Tendril leads was 7.0%, versus only 2.1% for the comparison group. Among the Tendril family, the 1888 TC model showed the highest failure rate at 9.9%, followed by the 1688 and 2088 models at 5.7% and 5.2%, respectively. These findings raise important questions about the design and materials used in Tendril leads.

Higher Malfunction Rates: Tendril leads had a significantly higher malfunction rate compared to other leads.
Specific Models at Risk: The Tendril 1888 TC model showed the highest failure rate.
Long-Term Concerns: Malfunction rates increased over time, particularly after five years.
Impact on Patients: Lead malfunctions can lead to additional surgeries and interventions.

One key aspect of the study focused on the role of Optim insulation, a silicone-polyurethane copolymer used in the 1888 and 2088 Tendril models. While Optim was intended to improve abrasion resistance, the study found that leads with Optim insulation actually had higher malfunction rates over the long term. Specifically, after ten years, the malfunction rate for Optim-insulated Tendril leads was 24.5%, compared to 7.1% for the non-Optim insulated 1688 model. This suggests that Optim insulation, while potentially beneficial in some respects, may have unforeseen drawbacks that contribute to lead failure.

Protecting Your Heart: What You Need to Know

The Heart Rhythm study provides valuable insights into the long-term performance of pacemaker leads, highlighting potential risks associated with the Abbott/St. Jude Tendril family, particularly those with Optim insulation. If you have a pacemaker with Tendril leads, it's crucial to discuss these findings with your cardiologist. Regular check-ups, remote monitoring, and open communication with your healthcare team are essential for ensuring the continued safety and effectiveness of your device. While this study sheds light on potential issues, it also underscores the importance of ongoing research and innovation in the field of cardiac pacing, with the ultimate goal of improving patient outcomes and enhancing the reliability of these life-saving devices.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1016/j.hrthm.2018.10.024, Alternate LINK

Title: Long-Term Performance Of A Pacing Lead Family: A Single-Center Experience

Subject: Physiology (medical)

Journal: Heart Rhythm

Publisher: Elsevier BV

Authors: Mikhael F. El-Chami, Birju Rao, Anand D. Shah, Carolyn Wood, Michael Sayegh, Patrick Zakka, Krista Ginn, Lauren Pallotta, Bryanna Evans, Michael H. Hoskins, David Delurgio, Michael Lloyd, Jonathan Langberg, Angel R. Leon, Faisal M. Merchant

Published: 2019-04-01

Everything You Need To Know

What specific types of pacing leads were examined in the Heart Rhythm study, and how was their performance evaluated?

The research focused on the Abbott/St. Jude Tendril pacing lead family and compared their performance to other pacing leads such as Medtronic CapSure Fix Novus and Boston Scientific Fineline II Sterox Pacing EZ Leads. The primary measure was the incidence of lead malfunction, assessed using Kaplan-Meier analysis over a decade at a single center.

According to the Heart Rhythm study, what were the malfunction rates observed in Tendril leads compared to other types of pacing leads?

The Heart Rhythm study indicated that Tendril leads, particularly the 1888 TC model, exhibited higher malfunction rates compared to non-Tendril leads. For example, over five years, Tendril leads had a malfunction rate of 7.0%, while the comparison group experienced only 2.1%. The 1888 TC model specifically showed a failure rate of 9.9%.

What is Optim insulation, and what role did it play in the performance of Tendril leads as revealed by the Heart Rhythm study?

Optim insulation is a silicone-polyurethane copolymer used in some Tendril lead models, such as the 1888 and 2088. While intended to enhance abrasion resistance, the Heart Rhythm study found that Tendril leads with Optim insulation had higher malfunction rates over the long term. After ten years, these leads showed a malfunction rate of 24.5%, significantly higher than the 7.1% rate of the non-Optim insulated 1688 model.

What steps should patients with pacemakers and Tendril leads take to protect their heart health, based on the findings of the Heart Rhythm study?

If you have a pacemaker with Tendril leads, especially those with Optim insulation, it is important to discuss the Heart Rhythm study findings with your cardiologist. Regular check-ups, remote monitoring, and clear communication with your healthcare team are essential to ensure the continued safety and effectiveness of your device. These steps can help monitor lead performance and detect potential issues early.

What are the broader implications of the Heart Rhythm study for the future of pacemaker technology and research in cardiac pacing?

The observed malfunctions in Tendril leads, particularly those with Optim insulation, highlight the importance of ongoing research and innovation in cardiac pacing. Future developments may focus on improving lead design, materials, and insulation to enhance reliability and reduce malfunction rates. Further investigations may explore alternative materials or designs to mitigate the risks associated with specific components like Optim insulation, aiming to improve patient outcomes and the longevity of pacemaker leads.