Download Needs to Know - Preventive Cardiovascular Nurses Association

Device‐Based Therapy of Cardiac Rhythm Abnormalities: The “Needs to Know”
Robin J. Trupp PhD, ACNP‐BC, CHFN
Duke University Medical Center
Durham, NC
Disclosures
I have no disclosures related to this presentation
Applying Classification of Recommendations and Level of Evidence
Class I
Class IIa
Class IIb
Class III
Benefit >>> Risk
Benefit >> Risk
Additional studies with
focused objectives
needed
Benefit ≥ Risk
Additional studies with
broad objectives needed;
Additional registry data
would be helpful
Risk ≥ Benefit
No additional studies
needed
Procedure/ Treatment
SHOULD be
performed/
administered
IT IS REASONABLE to
perform
procedure/administer
treatment
Procedure/Treatment
MAY BE CONSIDERED
Level of Evidence:
Level A:
Data derived from multiple randomized clinical trials or meta-analyses
Multiple populations evaluated;
Level B:
Data derived from a single randomized trial or nonrandomized studies
Limited populations evaluated
Level C:
Only consensus of experts opinion, case studies, or standard of care
Very limited populations evaluated
Procedure/Treatment
should NOT be
performed/administered
SINCE IT IS NOT
HELPFUL AND MAY
BE HARMFUL
Comparison Between ACC/AHA HF Stages and NYHA Functional Class
ACC/AHA HF Stage
A At high risk for heart failure but without
structural heart disease or symptoms
of heart failure (eg, patients with
hypertension or coronary artery disease)
B Structural heart disease but without
symptoms of heart failure
C Structural heart disease with prior or
current symptoms of heart failure
NYHA Functional Class
None
I Asymptomatic
II Symptomatic with moderate exertion
III Symptomatic with minimal exertion
IV Symptomatic at rest
D Refractory heart failure requiring
specialized interventions
CRM Devices
• Implanted Cardioverter Defibrillators
– Primary prevention
– Secondary prevention
• Pacing for hemodynamic indications
– Disorders of impulse conduction
– Cardiac resynchronization
• Implanted Hemodynamic Monitors
Implantable Cardioverter‐Defibrillators
Magnitude of SCA in the US
Stroke3
Lung
Cancer2
SCA claims more lives each year than these other diseases combined
Sudden
Cardiac
Arrest
Breast
Cancer2
AIDS1
The #1 Cause of Death
1
2
3
4
U.S. Census Bureau, Statistical Abstract of the United States: 2001.
American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures 2001.
2002 Heart and Stroke Statistical Update, American Heart Association.
Circulation. 2001;104:2158-2163.
Magnitude of SCA in the US
- ~ 450,000 per year1
•
1,200 events per day
•
•
50 every hour
1 every 80 seconds
‐ Majority of SCA occurs in patients with clinically recognized heart disease, particularly previous myocardial infarction and congestive heart failure.2,3
• 80%‐90% of SCD caused by ventricular fibrillation
1Circulation.
2001;104:2158-2163.
2
Myerburg RJ, Castellanos A. Cardiac Arrest and Sudden Cardiac Death, in Braunwald E, Zipes DP, Libby P,
Heart Disease, A textbook of Cardiovascular Medicine. 6th ed. 2001. W.B. Saunders, Co.
3
Every N, et al. Risk of Sudden versus Non Sudden Cardiac Death in Patient with Coronary Artery Disease.
Am Heart J 2002; 144: 390-6.
Implantable Cardioverter‐Defibrillators I IIa IIb
IIb III
III
ICD therapy is indicated in patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. I IIa IIb III
ICD therapy is indicated in patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. I IIa IIb III
ICD therapy is indicated in patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
Major ICD Trials for Primary Prevention of SCD
Trial
Year
Patients
(n)
Inclusion
Criterion:
LVEF
Additional Study
Features
Hazard
Ratio*
95% CI
p
MADIT I
1996
196
< 35%
NSVT and EP+
0.46
(0.26-0.82)
p=0.009
MADIT II
2002
1232
< 30%
Prior MI
0.69
(0.51-0.93)
p=0.016
CABG-Patch
1997
900
< 36%
+SAECG and CABG
1.07
(0.81-1.42)
p=0.64
DEFINITE
2004
485
< 36%
NICM, PVCs or NSVT
0.65
(0.40-1.06)
p=0.08
DINAMIT
2004
674
< 35%
6-40 days post-MI
and Impaired HRV
1.08
(0.76-1.55)
p=0.66
SCD-HeFT
2006
1676
< 35%
Prior MI or NICM
0.77
(0.62-0.96)
p=0.007
AVID
1997
1016
< 40%
Prior cardiac Arrest, or
Unstable VT
0.62
(0.43-0.82)
p<0.02
CASH†
2000
191
Mean < 45%
±18 at
baseline
Prior cardiac arrest
0.766
‡
1-sided
p=0.081
CIDS
2000
659
< 35%
Prior cardiac Arrest,
Unstable VT, or Syncope
0.82
(0.60-1.1)
NS
Implantable Cardioverter‐Defibrillators I IIa IIb
IIb III
III
I IIa IIb III
ICD therapy is indicated in patients with LVEF < 35% due to prior MI who are at least 40 days post‐MI and are in NYHA functional Class II ‐ III. ICD therapy is indicated in patients with nonischemic DCM who have an LVEF < 35% and who are in NYHA functional Class II ‐ III. I IIa IIb
IIb III
III
ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 days post‐MI, have an LVEF< 30% , and are in NYHA functional Class I. I IIa IIb III
ICD therapy is indicated in patients with nonsustained VT due to prior MI, LVEF < 40% , and inducible VF or sustained VT at electrophysiological study. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
LifeVest
FDA Indications for Use
• Adult patients who
are at risk for
sudden cardiac
arrest and are not
candidates for or
who refuse an
implantable
defibrillator.
Deactivating ICDs
Many patients with ICDs:
• Have anxiety about receiving shocks
• Experience shocks while dying Few patients with ICDs:
• Have ever discussed device deactivation with their providers • Even know that device deactivation is an option
Advance directives: • Articulating goals and preferences for care at the end‐of‐life
• When it comes to devices, this rarely happens
– For patients with ICDs, death with dignity?
CRM Devices
• Implanted Cardioverter Defibrillators
– Primary prevention
– Secondary prevention
• Pacing for hemodynamic indications
– Disorders of impulse conduction
– Cardiac resynchronization
• Implanted Hemodynamic Monitors
MADIT II: Complications
New or Worsening HF1
• RV pacing causes ventricular dysynchrony and development of or worsening HF1‐3
• Seen in those with 40‐50% RV pacing
• <10% of ICD patients have a Class I pacing indication at the time of implant.
(p= 0.09)
N= 490
N= 742
• Whenever appropriate, should consider programming of ICDs to avoid frequent RV pacing.4
1
Moss AJ. N Engl J Med. 2002;346:877‐83.
The DAVID Trial Investigators. JAMA 2002; 288: 3115‐3123.
3 The DAVID Trial Investigators. JAMA 2002; 288: 3115‐3123.
2
4
BEST. PACE. 1999;22 (1, part I):79-85.
QRS Duration and Mortality:
The VEST Trial
•
•
•
•
•
VEST study analysis
NYHA Class II‐IV patients
3,654 ECGs digitally scanned
Age, creatinine, LVEF, heart rate, and QRS duration found to be independent predictors of mortality
Relative risk of widest QRS group 5x greater than narrowest
QRS Duration (msec)
<90
90‐120
120‐170
170‐220
>220
Adapted from Gottipaty et al. JACC 1999; 33(2):145A (abstract 847‐4)
Achieving Cardiac Resynchronization
Leads for transvenous biventricular pacing
QRS Width Reduction ECG
‐‐‐‐‐‐‐Therapy OFF‐‐‐‐‐‐‐
‐‐‐‐‐‐‐‐‐Therapy ON‐‐‐‐‐‐‐‐‐
Lead V3
QRS=160 ms
QRS=120 ms
70% of patients with HF have QRS > 150 ms!
Recs Modified 2012
CRT in Patients With Systolic Heart Failure
I IIa IIb
IIb III
III
I IIa IIb
IIb III
III
I IIa IIb
IIb III
III
I IIa IIb III
CRT is indicated for patients who have LVEF < 35%, sinus rhythm, LBBB with a QRS duration >150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Level of Evidence: A for NYHA class III/IV; Level of Evidence: B for NYHA class II).1
CRT can be useful for patients who have LVEF < 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT.
CRT can be useful for patients who have LVEF < 35%, sinus rhythm, a non‐LBBB pattern with a QRS duration > 150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT.
1. Modified recommendation (specifying CRT in patients with LBBB of 150 ms; expanded to include those with NYHA class II symptoms).
Recs Modified 2012
CRT in Patients With Systolic Heart Failure
I IIa IIb
IIb III
III
I IIa IIb
IIb III
III
I IIa IIb
IIb III
III
CRT may be considered for patients who have LVEF < 35% , sinus rhythm, a non‐LBBB pattern with QRS duration 120 to 149 ms, and NYHA class III/ambulatory class IV on GDMT.
CRT may be considered for patients who have LVEF < 35%, sinus rhythm, a non‐LBBB pattern with a QRS duration > 150 ms, and NYHA class II symptoms on GDMT.
CRT is not recommended for patients with NYHA class I or II symptoms and non‐LBBB pattern with QRS duration <150 ms.
No Benefit
I IIa IIb
IIb III
III
No Benefit
CRT is not indicated for patients whose comorbidities and/or frailty limit survival with good functional capacity to less than 1 year.
Recs Modified 2012
CRT in Patients With Systolic Heart Failure
I IIa IIb
IIb III
III
I IIa IIb
IIb III
III
I IIa IIb III
CRT can be useful in patients with atrial fibrillation and LVEF < 35% on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT.1
CRT can be useful for patients on GDMT who have LVEF < 35% and are undergoing new or replacement device placement with anticipated requirement for significant (>40%) ventricular pacing.2
CRT may be considered for patients who have LVEF < 30% , ischemic etiology of heart failure, sinus rhythm, LBBB with a QRS duration > 150 ms, and NYHA class I symptoms on GDMT.
1. Modified recommendation (wording changed to indicate benefit based on ejection fraction rather than NYHA class; level of evidence changed from C to B).
2. Modified recommendation (wording changed to indicate benefit based on ejection fraction and need for pacing rather than NYHA class; class changed from IIb to IIa).
CRT – D Therapy
CRT
+
ICD
“Correction” of Conduction Delay
“Prevention” of Lethal Arrhythmias
Death or hospitalization for any cause
Bristow M et al, NEJM 2004;350:2140
Implanted Hemodynamic Monitors
CardioMems Champion HF Monitoring System
Laptop Clinical Trial
Using Heart Pod
Implantable Sensor Lead (ISL)
Lead
Distal Anchor
Proximal Anchor
Measures
•LAP
•IEGM
•Core Temp
Sensor Diaphragm ~ 3 mm
Sensor Module
Implantable Communications Module (ICM)
Meet “PAM” Patient Advisory Module
SAVACOR, INC
Modified PDA
•Powers through clothing
•Atmospheric reference
•Stores telemetry •Alerts patient to monitor
RA
LA
•‘DynamicRX®’ instructs
•Meds
•Activity
•Clinician contact based on LAP values and physician’s prescription
Minimum Frequency of CV Implantable Electronic Device (CIED) In‐Person or Remote Monitoring*
Type and Frequency
Pacemaker/ICD/CRT
 Within 72 h of CIED implantation  2–12 wk postimplantation  Every 3–12 mo for pacemaker/CRT‐Pacemaker
 Every 3–6 mo for ICD/CRT‐D  Annually until battery depletion
 Every 1–3 mo at signs of battery depletion
Implantable loop recorder
 Every 1– 6 mo depending on patient symptoms and indication Implantable hemodynamic monitor
 Every 1– 6 mo depending on indication  More frequent assessment as clinically indicated Method
In person
In person
In person or remote
In person or remote
In person
In person or remote
In person or remote
In person or remote
In person or remote
Wilkoff BL, Auricchio A, Brugada J, et al. HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm. 2008;5:907–25.
The Needs to Know...
1. CRM devices have same level of recommendation and strength of evidence as many medications
• Yet are frequently forgotten or deemed to be not necessary or not beneficial • Concordance of trials have shown improvement in important morbidity and mortality outcomes
2 When examining readmission rates, examine if pt is indicated for CRT + D • Documented discussion(s) with patient/family The Needs to Know...
3. CRM devices are not “rescue” therapy for those with advanced heart failure symptoms
• IV inotrope dependent, refractory fluid retention, advanced kidney disease
• Primary SCD ICD recommendations apply only to pts on optimal medical therapy and expectation of survival with good functional capacity for >1 yr
4. Discussions about end of life care should occur on a routine basis
• Include CRM devices
Questions?