Download ICDs in Primary Prevention

ICDs – Primary prevention
The EP Show: Guidelines and
reimbursement at the crossroads:
Primary prevention with ICDs
Eric Prystowsky MD
Director, Clinical Electrophysiology Laboratory
St Vincent Hospital
Indianapolis, IN
Stephen Hammill MD
Professor of Medicine
Mayo Clinic College of Medicine
Rochester, MN
Jeremy Ruskin MD
Director, Cardiac Arrhythmia Service
Massachusetts General Hospital
Boston, MA
EP Show – Dec 2003
ICDs – Primary prevention
Topic
ICDs in Primary Prevention:
MUSTT
MADIT
MADIT II
CABG-Patch
EP Show – Dec 2003
ICDs – Primary prevention
MUSTT
The Multicenter Unsustained Tachycardia
Trial
N Engl J Med 2002; 341:1882-90
• CAD patients with EF <40% and
nonsustained VT underwent EP testing
• If inducible, randomized to best medical
therapy or antiarrhythmic treatment
including an ICD
• Patients with sustained VT and an ICD
had a marked reduction in mortality;
those receiving drug therapy did not
show a mortality benefit
EP Show – Dec 2003
ICDs – Primary prevention
MADIT
Multicenter Autonomic Defibrillator
Implantation Trial
N Engl J Med 1996; 335:1933-40
• Patients with a history of MI, EF <35%
nonsustained VT, sustained VT
• Randomized to best medical therapy
(50% on amiodarone)or an ICD
• Approximately 50% reduction in
mortality with the ICD
EP Show – Dec 2003
ICDs – Primary prevention
CABG Patch
• 910 patients who underwent coronary
artery bypass grafting, with EF <35%,
randomized to an ICD or not
• Patients did not derive any benefit from
the ICD during follow-up
EP Show – Dec 2003
ICDs – Primary prevention
MADIT II
Multicenter Autonomic Defibrillator
Implantation Trial II
N Engl J Med 2002; 346:877-83
• 1232 patients from 71 US centers and 5
European centers with a history of MI, EF
<30%, randomized to an ICD or
conventional medical therapy
• Patients with an ICD had a better
survival outcome
EP Show – Dec 2003
ICDs – Primary prevention
Meta-analysis
All-cause mortality
Trial
MUSTT
ICD group
(%)
22
MADIT
16
CABG
Patch
MADIT II
23
EP Show – Dec 2003
14
Control
RR
group (%) (95% CI)
45
0.49
(0.35-0.67)
39
0.41
(0.24-0.69)
21
1.08
(0.84-1.39)
20
0.71
(0.56-.92)
Ann Intern Med 2003; 138:445-52
ICDs – Primary prevention
Definite answers
MADIT, MUSTT
•Striking impact on mortality with ICD
therapy
•No active patient recruitment; for
patients meeting criteria we follow the
guidelines from those two trials
•Only 15% to 20% of all ICD recipients
Ruskin
EP Show – Dec 2003
ICDs – Primary prevention
Reimbursement
MADIT II
•Issues around reimbursement and
patient selection
•Option of an ICD considered for MADITII patients meeting reimbursement
criteria
Ruskin
EP Show – Dec 2003
ICDs – Primary prevention
Power of revascularization
CABG Patch
•Speaks to the power of a complete
revascularization procedure on risk for
sudden death
•Inducibility at EP study allowed low-risk
patients to get into the study
•Benefits of the ICD may have been
diluted
Ruskin
EP Show – Dec 2003
ICDs – Primary prevention
Paradox
•Patients who never had VT or VF
undergoing CABG have no additional
benefit with ICD
•CABG alone is not enough in patients
with sustained VT or cardiac arrest
Prystowsky
"A very good point."
Ruskin
EP Show – Dec 2003
ICDs – Primary prevention
Patient characteristics
VT on the basis of scar or abnormal substrate
around the scar:
•Revascularization alone does not
eliminate VT, because it doesn't alter the
substrate
VF and well-preserved ventricular function:
•Revascularization is a very powerful
intervention
EP Show – Dec 2003
Ruskin
ICDs – Primary prevention
Outcome predictors
Three powerful independent predictors of
favorable outcome in cardiac-arrest
survivors:
•Ejection fraction
•ICD presence
•Revascularization
EP Show – Dec 2003
ICDs – Primary prevention
Guidelines
Why does MADIT I, with 196 patients, get a
class 1 indication, whereas MADIT II, with
over 1200 patients, only receives a class 2A
indication?
"I'm not sure that there's a clear reason."
•Perhaps today confirmatory trials are
awaited
"It seems that . . . people are setting the bar
higher."
Hammil
EP Show – Dec 2003
ICDs – Primary prevention
Changing paradigms
Why should we not go out looking for these
patients? We have a way to save lives.
Prystowsky
A change in paradigm:
"It took the American Heart a decade
or longer to get people to thinking
about 'what is your cholesterol level?'
We are at that point with defibrillator
treatment to prevent sudden death."
Hammill
EP Show – Dec 2003
ICDs – Primary prevention
Heart Rhythm Society
Campaign: "Learn your EF"
Part of the Heart Rhythm Foundation
looking at several areas of rhythm
disturbances, one of them sudden
death, focusing on EF
Stephen Hammill, incoming
president, Heart Rhythm
Society
EP Show – Dec 2003
ICDs – Primary prevention
Patient eligibility
Why are not many electrophysiologists
literally beating the bushes for these
patients?
History of ICD therapy: a consistent but
slow process of lowering resistance to
implantation
Concern at two levels:
•Not every patient meeting MADIT IIcriteria fits the study population
•Huge cost
Ruskin
EP Show – Dec 2003
ICDs – Primary prevention
QRS
Subgroup analysis:
Wider QRS
increased risk of an event
improved benefit from the device
Reduction in
mortality with ICD
(%)
EP Show – Dec 2003
QRS duration
>120 ms
50
QRS duration
<120 ms
25
ICDs – Primary prevention
Uncomfortable situation
Studies are never powered to do these
subgroup analyses with great confidence
At our practice at the Mayo Clinic:
•Patient younger than 65 meeting MADITII criteria gets an ICD
•Patient 65 or older must have QRS >120
ms to get an ICD
"It's an uncomfortable situation for the
physician."
Hammill
EP Show – Dec 2003
ICDs – Primary prevention
Age discrimination
"This is age discrimination. If
somebody is 64 and 364 days, what's
the difference to someone who is 65,
except that one gets reimbursed and
the other doesn't."
Prystowsky
"I agree, it's simply unacceptable."
It puts physicians in an impossible
situation. One has to work within
reimbursement guidelines.
EP Show – Dec 2003
Ruskin
ICDs – Primary prevention
Subgroup analyses
Subgroup analyses are hypothesesgenerating exercises, not to be used as hard
answers.
Prystowsky
"It doesn't seem scientifically
reasonable for these subgroup analyses
to be used in a pseudoscientific way to
set reimbursement policies."
Ruskin
•Excludes 70% of the Medicare
population
EP Show – Dec 2003
ICDs – Primary prevention
Rationing medical care
Heart Database:
•Close to 78% of 1100 patients meeting
MADIT-II criteria fell out once the QRS
criterion was added
"The worst of rationing medical care,
because it is not rationing on anything
other than age."
EP Show – Dec 2003
Prystowsky
ICDs – Primary prevention
Cardiomyopathy
Patient: Nonsustained VT, EF 25%
•No guidelines that support placing a
device
Patients with dilated cardiomyopathy and
nonsustained VT are not getting a device in
our practice.
Patients needing a biventricular pacemaker
to treat HF who meet all necessary criteria
will receive a biventricular ICD, based on
the COMPANION trial.
Hammill
EP Show – Dec 2003
ICDs – Primary prevention
DEFINITE: Design
DEFibrillators in Nonischemic
Cardiomyopathy Treatment Evaluation
• 458 patients with LV dysfunction due to
nonischemic dilated cardiomyopathy, EF
<35%, and a history of spontaneous
premature complexes or nonsustained VT
• Randomized to standard medical therapy
plus ICD or medical therapy alone
EP Show – Dec 2003
ICDs – Primary prevention
DEFINITE: Outcome
Medical therapy
Medical therapy + ICD
13.8
All-cause mortality
(%)
14
12
10
8.1
p=0.06
8
6
4
2
0
AHA 2003
EP Show – Dec 2003
ICDs – Primary prevention
DEFINITE: Comment
•Positive trial that was underpowered:
more patients and longer follow-up
needed
•34% reduction in all-cause mortality
•More evidence that patients with
nonischemic cardiomyopathy and
severe LV dysfunction are at severe
risk for sudden death and benefit from
an ICD
•SCD-HeFT could provide more data
EP Show – Dec 2003
ICDs – Primary prevention
Clinical practice
I don't look for cardiomyopathy patients,
but if they fall on my doorstep I do an EP
study for induced sustained arrhythmia and
implant a defibrillator.
Prystowsky
ICDs for
•Patients with familial cardiomyopathy
•Cardiomyopathy patients presenting
with syncope
Hammill
EP Show – Dec 2003
ICDs – Primary prevention
ICDs in primary prevention: Wrap-up
•Review of all major trials in CAD put
into perspective
•Applicability of trial results in clinical
practice
•Reimbursement in conflict with true
data in guidelines
Moving in one other direction in the
cardiomyopathy group
"If SCD-HeFT comes out positive, it will
push us very much in that direction."
EP Show – Dec 2003
Prystowsky