Male-focused Studies
Current guidelines are based on trials where ~80% of the patients were men.20
Manage Heart failure Patients
With Cardiac Resynchronisation
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.
15 million
people are estimated to suffer from Chronic Heart Failure in Europe. HF causes more avoidable hospital admissions than Diabetes, Asthma, or COPD.1
26.7%
one-year mortality after an acute HF hospitalization, across member countries of the ESC.4
44.4%
of patients are re-admitted within one year of being hospitalized for HF.4
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 resynchronisation 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 hospitalisations10-15
*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 underutilisation of defibrillator therapy.16,17
CRT and ICD Evidence
Results are from different studies and are shown for illustrative purposes only. Study sizes, designs, and populations vary.
Companion10 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).
Why might CRT therapy be underutilised?
Reasons for CRT underutilisation in the general population and underserved communities.
Presented by
Marc Silver, M.D.
Medtronic Global Grand Rounds
February 2015
Female Patients are Undertreated
Underutilisation 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
Patients with new ICD/CRT-D indication, 2012–20163
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.
INDICATIONS AND ADOPTION OF CRT IN EUROPE
Understanding the indications, guidelines and current adoption of CRT among the member countries of the ESC.
Presented by
Kenneth Dickstein, M.D.
HF Association Discoveries. June 2020
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
‡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.
crt patient brochureeducational resources on medtronic academy
Courses to increase your understanding of CRT-D therapy.
Visit Medtronic Academy
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
Health at a Glace: Europe 2020. Organization for Economic Cooperation and Development (OECD), Paris, France. Available on-line at: https://doi.org/10.1787/23056088. Accessed January 24th, 2021.
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
Chioncel O, Mebazaa A, Harjola VP, et al. Clinical phenotypes and outcome of patients hospitalized for acute heart failure: the ESC Heart Failure Long-Term Registry. Eur J Heart Fail. Oct 2017;19(10):1242-1254.
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
Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. Aug 2016;18(8):891-975." and "Brignole M, Auricchio A, Baron-Esquivias G, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. Aug 2013;34(29):2281-2329.
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.