International Study Shows High Success Rates of Lead Removal Procedure in Patients with Cardiac Devices

Presented at Heart Rhythm 2016, first prospective, multinational study on rapidly growing procedure shows positive outcomes

May 05, 2016

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Allison Kassel
BRG Communications
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Shane Osborne
Heart Rhythm Society
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SAN FRANCISCO, May 5, 2016 – A new, large study shows that 95.7 percent of individual leads were successfully removed using a procedure called transvenous lead extraction (TLE). The ELECTRa (European Lead Extraction ContTRolled) Registry, hosted by the European Heart Rhythm Association (EHRA) a registered branch of the European Society of Cardiology (ESC), is the first multinational, multi-center, prospective registry of consecutive patients undergoing TLE. The research was presented today at Heart Rhythm 2016, the Heart Rhythm Society’s 37th Annual Scientific Sessions, and includes data from both high volume and low volume medical centers.

The rate of cardiac rhythm device implantation such as pacemakers or defibrillators is on the rise and therefore complications are increasing, leading to a parallel growth of the TLE procedure. There are occasions when it is necessary to remove a device and any associated leads when there is infection, venous occlusion, lead malfunction or failure, or safety alerts. While TLE has become a central treatment option for patients, the safety and efficacy can vary widely.

Data from 73 centers across 19 countries of the ESC were collected using a web-based system. The primary objective was to evaluate the acute and long-term safety of TLE. The secondary objective included the description of patient characteristics, types of leads, indications for TLE, extraction techniques, success rates of TLE and the comparison between low and high volume centers. A high volume center is considered one that sees an average of 30 patients a year (or 2.5 patients a month) and a low volume center sees less than 30 patients per year.

A total of 3,555 consecutive patients undergoing extraction of 6,493 leads were enrolled in the registry. Leads were extracted from the right atrium, right ventricle, coronary sinus and other locations. Major and minor complications were 2.7 percent and 5.2 percent, respectively. High volume centers had fewer major (2.4 percent vs. 4.1 percent) and minor (4.5 percent vs 8.1 percent) complications compared to low volume centers. Procedure-related major complications occurred in 58 patients (1.7 percent). The most common procedure related complications were cardiovascular complications requiring surgical repair, pericardiocentesis or chest drain insertion.

“The success rates of our study were higher than originally predicted, which is encouraging. This is the first time that we’re seeing the safety of transvenous lead extraction in a large group of patients on a prospective, consecutive basis, which is clinically important. We can now use these results to further testify that TLE is an effective option to improve the quality of care for patients undergoing lead extraction,” said Maria Grazia Bongiorni, MD, University Hospital of Pisa in Italy. “While we saw great success rates, device therapy still poses many risks and complications, so it’s important that we continue to explore and push the boundaries for new technologies like embracing leadless pacemakers as the way of the future.”

The authors also looked at 12-month follow-up data and observed 3.2 percent of complications related to infection and 5.2 percent of complications related to non-infection conditions.

Sessions details:

“ELECTRa (European Lead Extraction ConTRolled) Registry: Long-term Outcomes on Transvenous Lead Extraction in Europe” [Thursday, May 5, 2016, 8:00 a.m.– 9:30 a.m. PDT, Room 2007, Moscone West]

Heart Rhythm 2016 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

About the Heart Rhythm Society

The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of more than 5,900 heart rhythm professionals in more than 70 countries around the world. For more information, visit www.HRSonline.org .

About the European Heart Rhythm Association

The European Heart Rhythm Association (EHRA) is a registered branch of the European Society of Cardiology (ESC). Its aim is to improve the quality of life of the European population by reducing the impact of cardiac arrhythmias and reducing sudden cardiac death. EHRA promotes science and education in the field of cardiac arrhythmias with a special focus on AF. Besides patient engagement programs EHRA organizes scientific and educational events for physicians and allied professionals. In cooperation with other associations and societies EHRA promotes the quality of care for patients with atrial fibrillation with the publication of international consensus documents. Further information is available at www.escardio.org/EHRA

About the European Society of Cardiology

The European Society of Cardiology (ESC) represents more than 95 000 cardiology professionals across Europe and worldwide. Its mission is to reduce the burden of cardiovascular disease in Europe. Further information is available at www.escardio.org