356,000
The number of out-of-hospital cardiac arrests annually in the United States — nearly 90% of them are fatal.3
~5%
The estimated national out-of-hospital survival-to-discharge rate for emergency medical services (EMS)-assessed.4
1 life every 2 minutes
The number that SCA claims, taking more lives each year than breast cancer, lung cancer, or AIDS.5,6
Why an ICD?
Data analysis from prior and contemporary studies on ICD therapy effectiveness
Presented by
Gianluigi Savarese, M.D., Ph.D.
Medtronic Global Grand Rounds
February 2020
Clinical evidence
ICD and CRT-D therapies have been widely studied to show a significant improvement in all-cause mortality.
CRT and ICD evidence
Results are from different studies and are shown for illustrative purposes only. Study sizes, designs, and populations vary.
SCD-HeFT†1
single chamber ICD all-cause mortality
n = 1,676, 45.5 months median follow-up (p = 0.007)
† The study demonstrated a 5% rate of acute device-related complications and 9% rate of chronic complications.
SwedeHF analysis, 2019‡7
ICD all-cause mortality
n = 2,610, 1 year, propensity score matched analysis (p < 0.01)
‡ Complications have occurred in 5% of the patients at the time of implantation and in 9% later in the course of the trial.
ICD therapy is underutilized overall, and even more so with women and patients in underserved communities.2 By understanding our biases, together we can reverse these trends and give all patients access to life-saving therapy.
Patients with new ICD/CRT-D indication, 2012–20162
Why might ICD therapy be underutilized?
Data findings in ICD underutilization and disparities in care among populations
Presented by
Sana Al-Khatib, M.D., MHS
Medtronic Global Grand Rounds
February 2020
Male-focused studies
Current guidelines are based on trials where ~80% of the patients were men.8
Profile differences
Women with heart failure may have a different clinical profile and not get a left ventricular assessment.9
Device counseling
Rates of device counseling, which can influence acceptance, are lower in women.10
Differing symptoms
Differences in how symptoms are communicated can affect course of treatment.11
Who can benefit from ICD therapy?
Overview of the DANISH Study and putting results in perspective for nonischemic patients
Presented by
Michael Gold, M.D., Ph.D., FHRS
Medtronic Global Grand Rounds
February 2020
2017 AHA/ACC/HRS guidelines for implantable defibrillators12: Class I recommendations
Download this chart to quickly refer to the indications for ICD therapy for primary and secondary prevention. Patients should already be on optimized medical therapy and have a meaningful survival for at least one year.
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*
Major clinical studies and registries demonstrated a 5% rate of acute device-related complications and 9% rate of chronic complications with ICD therapy.
†
The study demonstrated a 5% rate of acute device related complications and 9% rate of chronic complications.
‡
Complications have occurred in 5% of the patients at the time of implantation and in 9% later in the course of the trial.
References
1
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. January 20,
2005;352 (3):225-237.
2
Curtis AB, et al. Improving Heart Failure Outcomes Across the Care Continuum. Presented at HRS 2019; San Francisco, CA.
3
Benjamin EJ, Virani SS, Callaway CW, et al. Heart Disease and Stroke Statistics — 2018 Update: A Report From the American Heart Association. Circulation. March 20, 2018;137(12):e67-e492.
4
Daya M, Schmicker R, May S, Morrison L. Current burden of cardiac arrest in the United States: Report from the Resuscitation Outcomes Consortium. Paper commissioned by the Committee on the Treatment of Cardiac Arrest: Current Status and Future Directions. June 30, 2015.
5
Sudden Cardiac Arrest (SCA). Heart Rhythm Society. Available at https://upbeat.org/heart-rhythm-disorders/sudden-cardiac-arrest. Accessed November 5, 2020.
6
Myerburg RJ, Junttila MJ. Sudden cardiac death caused by coronary heart disease. Circulation. February 28, 2012;125(8):1043-1052.
7
Schrage B, Uijl A, Benson L, et al. Association Between Use of Primary-Prevention Implantable Cardioverter-Defibrillators and Mortality in Patients With Heart Failure. Circulation. November 5, 2019;140(19):1530-1539.
8
Zusterzeel R, Selzman K, Sanders WE, et al. Cardiac resynchronization therapy in women: US Food and Drug Administration meta-analysis of patient-level data. JAMA Intern Med. August 2014;174(8):1340-1348.
9
Lenzen MJ, Rosengren A, Scholte op Reimer WJ, et al. Management of patients with heart failure in clinical practice: Differences between men and women. Heart. March 2008;94(3):e10.
10
Hess PL, Hernandez AF, Bhatt DL, et al. Sex and Race/Ethnicity Differences in Implantable Cardioverter-Defibrillator Counseling and Use Among Patients Hospitalized With Heart Failure. Circulation. August 16, 2016;134(7):517-526.
11
Women in EP Working Group Meeting. HRS 2019. Data on file.
12
Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. September 25, 2018;138(13):e210-e271.
13
Devices supported on the CareLink network. January 2014. Data on file.