Manage Heart Failure Patients With Cardiac Resynchronization Therapy Defibrillators (CRT-D)
Because the heart can’t wait.
Heart failure (HF) is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body’s needs for blood and oxygen. It creates many personal challenges for patients, including decreased quality of life, restricted daily activities, and increased anxiety.
670,000
new HF cases are diagnosed annually in the United States — 26 million new cases worldwide.1
Common Cause
of hospitalizations due to cardiovascular disease in patients over 65.5
50%
mortality at 5 years.6
Although guideline-directed medication therapy (GDMT) can help to reduce mortality, often medication alone is not enough.2 For HF patients with electrical dyssynchrony, cardiac resynchronization therapy (CRT) — in addition to GDMT — is the only therapy clinically proven to help7:
- Improve quality of life8,9
- Slow HF disease progression10
- Decrease mortality11-15
- Reduce HF hospitalizations11-16
*Although many individuals benefit from the use of this treatment, results may vary. Risks associated with these implantable device systems include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed.
Why CRT for Heart Failure
Few therapies in all of medicine have the breadth and depth of supporting clinical data as CRT.
Presented by
Michael Gold M.D., Ph.D., FHRS
Medtronic Global Grand Rounds
December 2018
New Data: Redefining CRT Response
In a new analysis of results from the REVERSE trial,17 mild HF patients who received CRT were classified as improved, stabilized, or worsened based upon:
- Clinical composite score (CCS)
- Change in left ventricular end systolic volume index (LVESVi)
Apart from rare, isolated situations, heart failure is incurable ... a slowing of a progressive disease is a positive outcome.18
When CRT is used in patients who meet guideline-recommended indications, there is no proven patient population that experiences a negative response to CRT.18
Patients who stabilize with CRT have a much better prognosis than previously appreciated — suggesting that the current classification of “non-responder” is not appropriate.17
Clinical Trials
Major CRT clinical trials continue to show benefits for patients with electrical dyssynchrony.7-16 Clinical trials also highlight current underutilization and show the benefit of defibrillator therapy.19,20
CRT and ICD Evidence
Results are from different studies and are shown for illustrative purposes only. Study sizes, designs, and populations vary.
Companion11 CRT-D All-cause Mortality†
n = 903, 12 months mean follow-up
(p = 0.003)
†A total of 61% of patients in the pharmacologic therapy group had a moderate or severe adverse event from any cause, as compared with 66% of patients in the pacemaker group (P = 0.15) and 69% of patients in the pacemaker-defibrillator group (P = 0.03).
Heart Failure is a Growing Burden for Healthcare Systems
- > 8 million U.S. patients projected to have HF by 203023
- 34% of total Medicare spend attributable to HF patients24
- > 2 per year average HF hospitalizations per Medicare patient25
- ~$15,000 average healthcare system cost of a HF hospitalization‡25
Heart failure admissions are costly, and on average, Medicare reimbursement does not cover the hospital costs. This poses distinct challenges for healthcare providers and device patients.
‡Includes facility, professional, pharmacy, and patient responsibility for HF primary diagnosis.
Average Facility Margin Loss per Medical Management Hospitalization
$1,110 to $1,540 — range of average facility margin loss per medical management HF hospitalization26
Annual HF Hospitalization Rate§
Compared to medication alone, CRT-D is estimated to decrease annual HF hospitalization by 30%3
§Annual HF hospitalization rate estimates the average number of heart failure-related hospitalizations a patient in this cohort may have over a year. That is, in the example above, an optimal pharmacological therapy patient experiences 0.6 heart failure hospitalizations on average per year.
Why Might CRT Therapy be Underutilized?
Reasons for CRT underutilization in the general population and underserved communities.
Presented by
Marc Silver, M.D.
Medtronic Global Grand Rounds
February 2015
Female Patients are Undertreated4
Underutilization is especially pronounced in female patients.4 Studies have demonstrated a lack of female representation in clinical trials, key differences in clinical profiles, and biases in both physicians and patients.27-30
Male-focused Studies
Current guidelines are based on trials where ~80% of the patients were men.27
Profile Differences
Women with HF may have a different clinical profile and not get a left ventricular assessment.28
Device Counseling
Rates of device counseling, which can influence acceptance, are lower in women.29
Differing Symptoms
Differences in how symptoms are communicated can affect course of treatment.30
Patients with New ICD/CRT-D Indication, 2012–20164
Furthermore, women are shown to be different at baseline and have repeatedly shown superior outcomes from CRT than men.27
AdaptResponse Baseline31
Differences in Women and Men
The proportion of women enrolled in the AdaptResponse trial (43%) exceeds the proportion of women in other landmark CRT studies31 and approaches the proportion of women with HFrEF in the real world. This will allow unprecedented insights into the presentation, progression, and treatment of women with HF.
Who Can Benefit from CRT Therapy?
Understanding the indications and guidelines for qualifying patients for CRT.
Presented by
Jack Rickard, M.D.
Medtronic Global Grand Rounds
December 2018
Patients|| Who May Benefit from Co-management with an EP32
Indications of HF patients who may benefit from CRT:
- Low LVEF
- Wide QRS
- Frequent RV pacing
||Patients on stable, optimal heart failure medical therapy, if indicated.
These considerations are provided for general educational purposes only and should not be the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events: manuals.medtronic.com.
| Class I Guidelines — CRT-D |
CRT-D37 |
|
|---|---|---|
| Guideline Class and LOE |
IB |
IA |
| NYHA Class |
II |
III, IV |
| HF Etiology |
Ischemic, nonischemic |
|
| Left Ventricular Ejection Fraction (LVEF) |
≤ 35% |
≤ 35% |
| QRS Duration and Morphology |
QRS ≥ 150 ms, LBBB |
|
| RV Pacing |
Not specified |
|
| Guideline-directed Medical Therapy (GDMT) |
Yes |
|
Additional Resources
Educate Your Patients
Download conversation tools to explain the benefits of CRT-D and ICD therapies.
Therapy Awareness Programs
We’ll work with your clinic or medical center to provide presentations, data, and resources to support your staff’s understanding of lifesaving device therapies.
Educational Resources On Medtronic Academy
Courses to increase your understanding of CRT-D therapy.
Visit Medtronic Academy
References
1
Ambrosy AP, Fonarow GC, Butler J, et al. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. April 1, 2014;63(12):1123-1133.
2
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.
3
Medtronic Blueprint Economic Simulation Model for EV of CRT. Heart failure hospitalization rate based on Shah D, et al. Journal of Medical Economics. 2020;23:690-697. Heart failure hospitalization cost based on data from the Centers for Medicare and Medicaid Services and Premier Healthcare Database. Medtronic data on file. Actual results may vary.
4
Curtis AB, et al. Improving Heart Failure Outcomes Across the Care Continuum. Presented at HRS 2019; San Francisco, CA.
5
Cowie MR, Mosterd A, Wood DA, et al. The epidemiology of heart failure. Eur Heart J. February 1997;18(2):208-225.
6
Writing Group Members, Mozaffarian D, Benjamin EJ, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. January 26, 2016;133(4):e38-e360.
7
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J. August 2006;27(16):1928-1932.
8
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
9
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. May 28, 2003;289(20):2685-2694.
10
Gold MR, Padhiar A, Mealing S, Sidhu MK, Tsintzos SI, Abraham WT. Long-Term Extrapolation of Clinical Benefits Among Patients With Mild Heart Failure Receiving Cardiac Resynchronization Therapy: Analysis of the 5-Year Follow-Up From the REVERSE Study. JACC Heart Fail. September 2015;3(9):691-700.
11
Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. May 20, 2004;350(21):2140-2150.
12
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. April 14, 2005;352(15):1539-1549.
13
Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. October 1, 2009;361(14):1329-1338.
14
Tang AS, Wells GA, Talajic M, et al. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. December 16, 2010;363(25):2385-2395.
15
Curtis AB, Worley SJ, Adamson PB, et al. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med. April 25, 2013;368(17):1585-1593.
16
Linde C, Abraham WT, Gold MR, et al. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. December 2, 2008;52(23):1834-1843.
17
Gold MR, Rickard J, Daubert JC, Zimmerman P, Linde C. Redefining the Classifications of Response to Cardiac Resynchronization Therapy: Results From the REVERSE Study. JACC: Clin Electrophysiol. Published online February 24, 2021.
18
Mullens W, Auricchio A, Martens P, et al. Optimized implementation of cardiac resynchronization therapy – a call for action for referral and optimization of care. Eur J Heart Fail. Published online November 2, 2020.
19
Køber L, Thune JJ, Nielsen JC, et al. DANISH Investigators. Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. N Engl J Med. September 29, 2016;375(13):1221-1230.
20
Zobel M, et al. Clinical Effectiveness of Primary Prevention ICDs: Results of the EU-CERT-ICD Non-Randomised, Controlled, Multicentre Study. Presented at ESC 2019; Paris, France.
21
Benjamin EJ, Muntner P, Alonso A, et al. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. March 5, 2019;139(10):e56-e528.
22
The Cost Burden of Worsening Heart Failure in the Medicare Fee for Service Population: An Actuarial Analysis. Milliman Client Report. milliman.com. Available at: https://www.milliman.com/-/media/milliman/importedfiles/uploadedfiles/insight/2017/cost-bruden-worsening-heart-failure.ashx. Accessed February 3, 2021.
23
Kilgore M, Patel HK, Kielhorn A, Maya JF, Sharma P. Economic burden of hospitalizations of Medicare beneficiaries with heart failure. Risk Manag Healthc Policy. May 10, 2017;10:63-70.
24
Imperium Health Management, Kenley J. Analysis of costs and payments associated with DRGs 291-293 and diagnosis of heart failure using data from the Centers for Medicare and Medicaid Services and Premier Healthcare Database. Medtronic data on file.
25
Al-Khatib SM, Hellkamp A, Bardy GH, et al. Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. JAMA. January 2, 2013;309(1):55-62.
26
Schrage B, Uijl A, Benson L, et al. Association Between Use of Primary-Prevention Implantable Cardioverter-Defibrillators and Mortality in Patients With Heart Failure: A Prospective Propensity Score-Matched Analysis From the Swedish Heart Failure Registry. Circulation. November 5, 2019;140(19):1530-1539.
27
Zusterzeel R, Selzman KA, 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.
28
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.
29
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: Findings from the Get With The Guidelines-Heart Failure Program. Circulation. August 16, 2016;134(7):517-526.
30
Women in EP Working Group Meeting. HRS 2019. Data on file.
31
Wilkoff BL, Birnie D, Gold MR, et al. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. October 2020;7(5):2972-2982.
32
Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force On Practice Guideline. J Am Coll Cardiol. October 15, 2015;62(16):e147-e239.
33
Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877-883.
34
Cleland JG, Abraham WT, Linde C, et al. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. December 2013;34(46):3547-3556.
35
Linde C, Abraham WT, Gold MR, et al. Predictors of short-term clinical response to cardiac resynchronization therapy. Eur J Heart Fail. August 2017;19(8):1056-1063.
36
Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. June 17, 2003;107(23):2932-2937.
37
Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. January 22, 2013;61(3):e6-e75.