the impact of heart failure

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.

White icon depicting a person in a hospital bed

670,000

new HF cases are diagnosed annually in the United States — 26 million new cases worldwide.1

White icon of an H to represent a hospital

common cause

of hospitalizations due to cardiovascular disease in patients over 65.4

White icon of a clock

50%

mortality at 5 years.5

Improve Patient survival and quality of life*

Although guideline-directed medication therapy (GDMT) can help to reduce mortality, often medication alone is not enough.For HF patients with electrical dyssynchrony, cardiac resynchronization therapy (CRT) — in addition to GDMT — is the only therapy clinically proven to help6:

  • Improve quality of life7,8
  • Slow HF disease progression9
  • Decrease mortality10-14
  • Reduce HF hospitalizations10-15

*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

Clinical trials

Major CRT clinical trials continue to show benefits for patients with electrical dyssynchrony.6-15 Clinical trials also show the benefit of and highlight current underutilization of defibrillator therapy.16,17

CRT and ICD Evidence

Chart showing ICD and CRT studies done between 2011 and 2021.

Results are from different studies and are shown for illustrative purposes only. Study sizes, designs, and populations vary.

Companion10 CRT-D All-cause Mortality

Graph showing a 36% relative reduction in all-cause mortality shown in the Companion trial

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).

Help
Increase Utilization 

CRT-D therapy is underutilized overall, and even more so with women and patients in underserved communities.3 By understanding our biases, together we can reverse these trends and give all patients access to lifesaving therapy.

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 Undertreated

Underutilization is especially pronounced in female patients.3 Studies have demonstrated a lack of female representation in clinical trials, key differences in clinical profiles, and biases in both physicians and patients.20-23

Male-focused Studies

Current guidelines are based on trials where ~80% of the patients were men.20

Profile Differences

Device Counseling

Differing Symptoms

Differences in how symptoms are communicated can affect course of treatment.23

Patients with new ICD/CRT-D indication, 2012–20163

Graph showing that 12.7% of indicated women received an ICD or CRT-D versus the 16.7% of indicated men from 2012 to 2016

Furthermore, women are shown to be different at baseline and have repeatedly shown superior outcomes from CRT than men.20

AdaptResponse Baseline24 differences in women and men

The proportion of women enrolled in the AdaptResponse trial (43%) exceeds the proportion of women in other CRT studies (average 20–30%) 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.

Illustration showing factors that were considered in the AdaptResponse trial with men versus women

know who can benefit 

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 EP25

Indications of HF patients who may benefit from CRT:

  • Low LVEF
  • Wide QRS
  • Frequent RV pacing
Chart showing three indications heart failure patients may have who could benefit from an EP consult

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-D29

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

    

Educate your patients 

Download conversation tools to explain the benefits of CRT-D and ICD therapies.

SCA Patient Brochure

crt patient brochure

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.

Download Brochure

educational resources on medtronic academy

Courses to increase your understanding of CRT-D therapy.

Visit Medtronic Academy
Cobalt HF Quad CRT-D on a navy background

Our CRT-D Systems

Our full line of
CRTs and LV leads.

See Devices
Attain Stability Quad LV lead on a light blue background

Our CRT-D Features

Unique features to
tailor therapy for your
patient’s needs.

Explore Features
MyCareLink Heart Mobile app home screen on a smartphone on a blue background

Managing Your patients

Tools to keep you and your
patients connected.

Monitoring Options

Footnotes

*

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.

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).

Patients on stable, optimal heart failure medical therapy, if indicated.

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

Curtis AB, et al. Improving Heart Failure Outcomes Across the Care Continuum. Presented at HRS 2019; San Francisco, CA.

4

Cowie MR, Mosterd A, Wood DA, et al. The epidemiology of heart failure. Eur Heart J. February 1997;18(2):208-225.

5

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.

6

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.

7

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.

8

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.

9

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.

10

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.

11

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.

12

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.

13

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.

14

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.

15

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.

16

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):1221-30.

17

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.

18

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.

19

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.

20

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):1340-8.

21

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.

22

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.

23

Women in EP Working Group Meeting. HRS 2019. Data on file.

24

AdaptResponse baseline manuscript, “Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy,” was accepted July 2020 and published August 2020 in ESC Heart Failure.

25

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.

26

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.

27

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.

28

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.

29

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.