Feature | Implantable Cardioverter Defibrillator (ICD) | May 09, 2016

Positive Long-Term Outcomes For S-ICD System In the EFFORTLESS Study

International, multicenter EFFORTLESS study reports most recent, positive results on S-ICD safety and efficacy

S-ICD, Effortless

The S-ICD system is implanted without use of leads implanted in veins or inside the heart.

May 9, 2016 — The mid to long-term results from the EFFORTLESS study, the largest subcutaneous implantable cardioverter-defibrillator (S-ICD) registry in the world, show the device provides reliable treatment for ventricular tachyarrhythmias. This is the first report on the fully enrolled EFFORTLESS cohort and includes real-world outcomes of almost 1,000 patients implanted with an S-ICD. Positive results showing longevity during three- and up to five-year follow-ups were presented at Heart Rhythm 2016, the Heart Rhythm Society (HRS) annual meeting.

A conventional ICD includes leads, which can cause complications such as systemic infections, acute and chronic displacement, pneumothorax, cardiac perforation, tamponade and inappropriate shocks associated with insulation failure or lead fractures.[1,2] The S-ICD was therefore developed to manage ventricular arrhythmias without the need for intracardiac leads. Until this study, there has been no mid to long-term, real-world data that shows how the S-ICD performs in a multi-center, heterogeneous ICD population.[3]

The EFFORTLESS study enrolled 994 patients at 42 sites in nine European countries and New Zealand from August 2009 to December 2014. The average patient age was 48 years and 28 percent of patients were female. The average left ventricular ejection fraction was 43 percent, and 65 percent of patients had a primary prevention indication. The pre-defined endpoints were complications caused by the S-ICD at 30 and 360 days as well as inappropriate shocks for atrial fibrillation and supraventricular tachycardia. Primary results demonstrate low complication rates associated with the S-ICD device, with a complication-free rate of 99.7 percent at 30 days, and 98 percent at 360 days post-procedure.

The average follow-up time was three years, and five-year follow up was completed in eight percent of patients. Inappropriate therapy for atrial fibrillation/supraventricular tachycardia at one year was 1.5 percent, with a total inappropriate shock rate of 8.1 percent at one year, and 11.7 percent at three years. The one- and five-year rates of appropriate shock were 5.8 percent and 13.5 percent, respectively. Device extraction occurred due to infection in 24 patients (2.4 percent), failed conversion at implant in four (0.4 percent), and bradycardia pacing need in one (0.1 percent). There have been no reports of lead failure, endocarditis or mortality to date.

“For the first time, we’re reporting on the fully enrolled registry and seeing positive mid- and long-term results, which to date show that this device is safe and effective, even at the five-year mark,” said lead author Lucas V. A. Boersma, M.D., Ph.D., St. Antonius Hospital, Nieuwegein, Netherlands. “Now we are truly able to see the unique advantages of the S-ICD as compared to the conventional ICD, which will help clinicians meet individual patient need and improve overall patient care. This post-approval registry further confirms that not only is the Subcutaneous Implantable Defibrillator an effective therapy, but its benefits are consistent amongst the full range of indicated patient subsets."

Since this study began, there have been new software updates to the device that will greatly enhance future device performance. In fact, Boston Scientific’s EMBLEM S-ICD received FDA and CE mark approval in March 2016. Study authors stress the importance of continued research and innovation in this field as advancing technology improves patient care.

Since receiving CE mark and U.S. Food and Drug Administration approval for the S-ICD System in 2009 and 2012, respectively, Boston Scientific launched its next generation Emblem S-ICD system, which is 20 percent thinner and is projected to last 40 percent longer than the original S-ICD. Last month, the company was granted CE mark for the new Emblem MRI S-ICD system as well as magnetic resonance conditional labeling for all previously implanted Emblem S-ICD systems. In the U.S., the Emblem MRI S-ICD System and Empower Modular Pacing System are not available for use or sale.

For more information: www.sicdsystem.com

1. Reynolds MR, Cohen DJ, Kugelmass AD, Brown PP, Becker ER, Culler SD, Simon AW. The frequency and incremental cost of major complications among Medicare beneficiaries receiving implantable cardioverter defibrillators. J Am Coll Cardiol 2006;47:2493–2497.

2.  Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, Saggau W, Weisse U, Seidl K. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of .10 years. Circulation 2007;115: 2474–2480.

3. Lambiase PD, Barr C, Theuns DAMJ, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kääb S, Murgatroyd F, Reeve HL, Carter N, and Boersma L. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. European heart journal 2014: ehu112

Related Content

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo