Background Implantable cardioverter-defibrillator (ICD) shocks are associated with increased anxiety, health care utilization, and potentially mortality. Objective The purpose of the Shock-Less Study was to determine if providing feedback reports to physicians on their adherence to evidence-based shock reduction programming could improve their programming behavior and reduce shocks. Methods Shock-Less enrolled primary prevention (PP) and secondary prevention (SP) ICD patients between 2009 and 2012 at 118 study centers worldwide and followed patients longitudinally after their ICD implant. Center-specific therapy programming reports (TPRs) were delivered to each center 9 to 12 months after their first enrollment. The reports detailed adherence to evidence-based programming targets: number of intervals to detect ventricular fibrillation (VF NID), longest treatment interval (LTI), supraventricular tachycardia (SVT) discriminators (Wavelet, PR Logic), SVT limit, Lead Integrity Alert (LIA), and antitachycardia pacing (ATP). Clinicians programmed ICDs at their discretion. The primary outcome measure was the change in utilization of evidence-based shock reduction programming before (phase I, n = 2694 patients) and after initiation of the TPR (phase II, n = 1438 patients). Results Patients implanted after feedback reports (phase II) were up to 20% more likely to have their ICDs programmed in line with evidence-based shock reduction programming (eg, VF NID in PP patients 30/40 in 33.5% vs 18.6%, P <.0001). Patients implanted in phase II had a lower risk of all-cause shock (adjusted hazard ratio 0.72, 95% confidence interval 0.58-0.90, P =.003). Conclusion Providing programming feedback reports improves adherence to evidence-based shock reduction programming and is associated with lower risk of ICD shocks.
Bibliographical noteFunding Information:
This study was sponsored by Medtronic Inc. Dr. Silver has received honoraria for speaking engagements on behalf of Medtronic and has received consulting fees from Medtronic. Dr. Sterns has received honoraria for speaking engagements on behalf of Medtronic. Dr. Piccini has received grants for clinical research from ARCA biopharma, Boston Scientific, GE Healthcare, Johnson & Johnson, and Resmed, and has received consulting fees from Forest Laboratories, Janssen Pharmaceuticals, Medtronic, and Spectranetics. Dr. Ching has received consulting fees from Medtronic, St. Jude Medical, and Boston Scientific. Dr. Pickett has received consulting fees from Medtronic and has received compensation for research with Medtronic, Boston Scientific, St. Jude Medical, and Atritech. Shufeng Liu, Brett Peterson, and Dr. Lexcen are employed by and own stock in Medtronic Inc, the sponsor of the Shock-Less Study.
© 2015 Heart Rhythm Society.
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine
- Physiology (medical)