News | January 30, 2015

Studies Show Benefits of Medtronic SmartShock Technology and Physician Reports in Protecting Patients from Inappropriate Shocks

New results from PainFree SST, Shock-Less Studies involving nearly 7,000 patients published in HeartRhythm

Cardiac Resynchonization Therapy (CRT), Implantable cardioverster defibrillators

Image courtesy of Medtronic

January 30, 2015 — Medtronic announced new results from the PainFree SST and Shock-Less clinical studies published in the journal HeartRhythm. The data show that treating patients with Medtronic implantable cardiac devices equipped with SmartShock Technology, and that providing clinicians with proactive reports, help physicians deliver life saving therapy while avoiding inappropriate and unnecessary shocks.  

The studies evaluated cardiac resynchronization therapy-defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs), which stop life-threatening fast or irregular heartbeats by shocking or pacing the heart. While most ICD-delivered shocks are needed, previous studies estimated that approximately 20 percent of patients with ICDs may experience inappropriate shocks in response to benign arrhythmias or electrical noises sensed by their devices.  

The new PainFree SST study results show that the rate of inappropriate shocks for patients with the Medtronic SmartShock Technology was 1.5 percent with a dual/triple chamber defibrillator and 2.5 percent for single chamber ICD at one year after implant. At two years post-implant, 2.8 percent of dual/triple chamber and 3.7 percent of single chamber device patients experienced inappropriate shocks.

These results are consistent with earlier findings that showed 98 percent of patients with SmartShock technology are inappropriate shock-free at one year.

While PainFree SST data show the benefits of SmartShock Technology, the results from the Shock-Less clinical study demonstrate the importance of programming devices to improve "real world" patient outcomes. Most implanted ICDs are programmed to the manufacturer's default settings; however, the Shock-Less study showed that patients had better outcomes when their clinicians received guideline-based programming recommendations and periodic programming compliance reports prior to ICD implants.

Patients who received ICD implants after their clinicians received these reports were up to 20 percent more likely to have their ICDs programmed according to guidelines, and to have a lower risk of inappropriate shocks. Based upon the results of these studies, Medtronic modified the initial settings of its ICDs, thereby simplifying programming for physicians and optimizing outcomes for patients.

In addition to providing better patient care, previous studies have shown that preventing inappropriate shocks also can lower the rate of hospitalizations, resulting in cost savings (Medtronic ADVANCE III Trial).

PainFree SST is a prospective, multicenter study that enrolled 2,790 patients at 126 centers across the globe, all of whom received a new device implant, system upgrade or generator replacement. Patients were followed for up to four years, with visits every six months.  

Shock-Less is a prospective clinical study that enrolled 4,131 primary- and secondary-prevention patients with ICDs between 2009 and 2012 at 118 clinical sites. After first enrollments in the trial, clinicians received reports that displayed ICD parameter settings in relation to evidence-based targets (including number of intervals to detect Ventricular Fibrillation (VF), longest treatment interval, supraventricular tachycardia (SVT) discriminators, Lead Integrity Alert(TM) and anti-tachycardia pacing).

For more information:

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