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

Medtronic Shows Feasibility of New Approach to ICD Therapy

Studies presented at Heart Rhythm 2016 provide encouraging results for ICD lead placement under ribs, outside heart and veins

May 9, 2016 — Medtronic announced the results of several studies evaluating a novel approach to implantable cardioverter defibrillator (ICD) therapy at Heart Rhythm 2016, the Heart Rhythm Society (HRS) annual meeting. 

The Medtronic EV-ICD system, which currently is in development and not available for use or sale, is a new approach to ICD therapy with leads placed outside the heart and veins, and under the rib cage. The studies presented at HRS are the first to evaluate the new concept, and the results demonstrate that extravascular lead placement may provide the same benefits achieved with conventional ICDs, including pacing the heart in patients at risk of dangerous heart rhythms.
“While conventional ICDs are highly effective in providing life-saving therapy for patients at risk of sudden cardiac death, clinicians also are looking for an extravascular solution that provides similar benefits as transvenous ICDs, including pacing to terminate life- threatening heart rhythms,” said Joseph Chan, M.D., Prince of Wales Hospital, Hong Kong, who led one of the studies presented at Heart Rhythm. “The feasibility results presented are encouraging and show that the EV-ICD approach may be the solution physicians are seeking.”
The investigational Medtronic EV-ICD system consists of an implanted device, a newly designed lead, and procedure tools to guide the efficient delivery of the system. Like conventional ICDs, the system is designed to deliver life-saving electrical shocks to protect patients from sudden cardiac death, to deliver anti-tachycardia pacing (ATP) to pace the heart out of potentially life-threatening heart rhythms that can lead to sudden cardiac death, and to provide post-shock pacing. Like transvenous ICD systems, the Medtronic EV-ICD is projected to have longevity of approximately 10 years and an expected device volume of approximately 33 cc. In addition to these potential benefits, the EV-ICD approach is designed to prevent the rare, but potentially serious, risks that can occur when leads are implanted inside the vasculature and the heart.
In an oral abstract session, Chan presented the results from a prospective, non- randomized study of 16 patients scheduled to undergo a midline sternotomy or implant of an ICD, who were enrolled at five sites in Europe and Hong Kong. Using an introducer to guide the delivery of the defibrillation lead under the rib cage, the study determined that defibrillation is possible in this location with defibrillation results consistent with conventional ICDs.
In a second oral abstract session, Darius Sholevar, M.D., presented the results from a prospective, multicenter trial that assessed the feasibility of cardiac pacing from a lead placed outside the heart and under the rib cage (also referred to as extravascular, or substernal space). Substernal Pacing Acute Clinical Evaluation (SPACE) studied 26 patients from eight sites in the United States and Canada, and preliminary data demonstrated that pacing is possible from this extravascular space, with the majority of patients achieving consistent and appropriate ventricular pacing results.

 These clinical data were further supported by other pre-clinical abstracts presented during Heart Rhythm, which assessed the feasibility of pacing and defibrillation with leads outside the heart and under the rib cage:
·  Researchers developed a model to compare the amount of energy required for effective defibrillation in conventional ICDs, subcutaneous ICDs, and the investigational EV-ICD approach. The model showed that lead placement under the rib cage requires slightly more energy, on average, for defibrillation compared to conventional ICDs, and about half as much, on average, as current subcutaneous ICDs. These data were further supported by a second abstract demonstrating that the EV-ICD approach requires lower energy (defibrillation thresholds) than subcutaneous devices and comparable energy to conventional ICDs.

· A final abstract reinforced that pacing can be achieved with the lead placed in this extravascular space.
“The EV-ICD may be transformational for ICD therapy, with advancements for both patients and physicians,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the cardiac rhythm and heart failure division. “These feasibility study results are promising and have brought us one step closer to making this approach a reality for patients around the world at risk of sudden cardiac death.”
Sudden cardiac arrest is an abrupt loss of heart function that can result in death if not treated within minutes. Conventional ICDs involve leads (thin wires) connected to the heart to deliver shocks or ATP that restore normal heart rhythms. ICDs are proven to be 98 percent effective in treating dangerous ventricular arrhythmias that can lead to sudden cardiac arrest.[1,2]
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
For more information:

1. Zipes, DP, Roberts, D. for the Pacemaker-Cardioverter-Defibrillator investigators. Results of the International Study of the Implantable Pacemaker Cardioverter-Defibrillator: A Comparison of Epicardial and Endocardial Lead Systems. Circulation. 1995;92:59- 65.

2. Volosin et al. “Virtual ICD: A Model to Evaluate Shock Reduction Strategies.” Heart Rhythm. Vol. 7, N. 5, May supplement 2010. (PO3-125).

Related Content

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
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init