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May 08, 2019

Helping physicians manage chronic cardiac patient care: Philips highlights the critical role of lead management for cardiac implants

Estimated reading time: 4-6 minutes

       

In the run-up to the Heart Rhythm Society’s annual scientific sessions, Philips submitted its latest innovation in lead management for FDA clearance, advancing innovation in an increasingly important field.

 

Since their emergence over 60 years ago, implantable cardiac devices have made a significant positive impact for patients. Today, there are an estimated 13 million cardiac implanted electronic device leads worldwide, and another 1.4 million are implanted every year [1] [2]. With more devices installed than ever and, as a result, more complications, the long-term management of patients is increasingly important. From infection, to vascular issues, to challenges with leads or the cardiac device itself, there are many reasons why both leads and devices may need to be removed and replaced during a patient’s lifetime. Philips’ lead management portfolio helps clinicians take the best course of action for each individual patient.  

 

“As soon as a device is implanted, the patient’s anatomy starts to adapt. Over time, attachments form between the leads and the vessel walls, making their removal difficult and particular to each individual,” said Chris Duffie, Business Segment Leader for Lead Management at Philips. “Starting with the introduction of our laser system in 1997, we have led the way, continuously innovating in lead management and providing physicians with tools that are designed with safety in mind.” 

 

Philips’ laser sheaths incorporate optical fibers arranged in a circle. The energy emitted from the tip ablates the tissue holding the lead, thereby freeing the lead in a controlled fashion. Philips offers the only laser sheath indicated for use in lead extraction procedures.

The Philips Lead Management Portfolio
Starting with the introduction of our laser system in 1997, we have led the way, continuously innovating in lead management and providing physicians with tools that are designed with safety in mind.

Chris Duffie

Business Segment Leader for Lead Management at Philips

Another area where Philips is at the forefront of innovation is in addressing a rare but dramatic adverse event that can occur during lead extraction – a tear of the superior vena cava (SVC), the largest of the veins returning deoxygenated blood to the heart. While SVC tears during lead extraction are very rare, occurring in less than 0.5% of procedures, mortality rates used to average 50%, dissuading physicians from providing a potentially life-saving procedure [3]. The Philips Bridge occlusion balloon, introduced in 2016, gives physicians time to make a surgical repair. In a study of 91 patients that experienced an SVC tear, the survival rate for the 55 patients without the Bridge balloon was only 56.4% versus a survival rate of 91.7% in the 36 patients where the Bridge balloon was properly utilized [3].

 

Philips’ commitment to innovation continues with the recent FDA submission of a new powered dilator sheath – TightRail Guardian. The latest update in the Philips lead management portfolio includes a ‘shielded mode’ designed to prevent the dilation mechanism from contacting the vessel wall, and a comfortable, motorized handle to reduce fatigue, along with a range of innovations to make it easier to extract leads. 

The Philips Lead Management Portfolio
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Lead extraction procedures require a high level of expertise, and physicians require a wide range of tools to provide a tailored solution for each patient’s specific needs. “Our portfolio already includes a wide range of extraction solutions – laser, mechanical and manual sheaths that travel over the lead to free it from vessel tissue and easily remove it from the body,” continued Duffie. “The TightRail Guardian was designed based on clinician feedback to address some of the challenges with lead extraction. We firmly believe in managing every lead, safely, predictably and responsibly, and with our broad portfolio of tools, we’re supporting clinicians to provide the best care to their patients.”

 

To find out more about Philips’ lead management innovations, visit us on booth #742 at Heart Rhythm 2019 (May 8-11, San Francisco, U.S.).

 

[1] Millennium Research Group, Global Markets for Cardiac Rhythm Management Devices 2013.

[2] Eucomed (2012).

[3] Roger G. Carrillo, MD; Darren C. Tsang, BS; Ryan Azarrafiy, BA; Thomas A. Boyle, BS. Multi-Year Evaluation of Compliant Endovascular Balloon in Treating Superior Vena Cava Tears During Transvenous Lead Extraction. EHRA late-breaking trial, March 19, 2018.

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