EP Show – Dec 2003 ICDs – Primary prevention The EP Show: Guidelines and reimbursement at the crossroads: Primary prevention with ICDs Eric Prystowsky

EP Show – Dec 2003

ICDs – Primary prevention

The EP Show: Guidelines and reimbursement at the crossroads: Primary prevention with ICDs

Eric Prystowsky MDDirector, Clinical Electrophysiology Laboratory

St Vincent Hospital Indianapolis, IN

Stephen Hammill MD Professor of MedicineMayo Clinic College of MedicineRochester, MN

Jeremy Ruskin MD Director, Cardiac Arrhythmia ServiceMassachusetts General Hospital Boston, MA



ICDs in Primary Prevention:

MUSTT

MADIT

MADIT II

CABG-Patch

Topic



MUSTTThe 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



MADITMulticenter 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



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



MADIT IIMulticenter 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



Trial ICD group (%)

Control group (%)

RR(95% CI)

MUSTT 22 45 0.49(0.35-0.67)

MADIT 16 39 0.41(0.24-0.69)

CABG Patch

23 21 1.08 (0.84-1.39)

MADIT II 14 20 0.71(0.56-.92)

Meta-analysis

Ann Intern Med 2003; 138:445-52

All-cause mortality



Definite answersMADIT, 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



ReimbursementMADIT II

•Issues around reimbursement and patient selection

•Option of an ICD considered for MADIT-II patients meeting reimbursement criteria

Ruskin



Power of revascularizationCABG 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



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



Patient characteristicsVT 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

Ruskin



Outcome predictorsThree powerful independent predictors of favorable outcome in cardiac-arrest survivors:

•Ejection fraction

•ICD presence

•Revascularization



GuidelinesWhy 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



Changing paradigmsWhy 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



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



Patient eligibilityWhy 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 II-

criteria fits the study population•Huge cost

Ruskin



QRSSubgroup analysis:

Wider QRS increased risk of an event improved benefit from the device

QRS duration >120 ms

QRS duration <120 ms

Reduction in mortality with ICD (%)

50 25



Uncomfortable situationStudies are never powered to do these subgroup analyses with great confidence

At our practice at the Mayo Clinic:

•Patient younger than 65 meeting MADIT-

II 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



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.

Ruskin



Subgroup analysesSubgroup analyses are hypotheses-generating 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



Rationing medical careHeart 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."

Prystowsky



CardiomyopathyPatient: 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



DEFINITE: DesignDEFibrillators 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



DEFINITE: Outcome

13.8

8.1

02468

101214

All-

caus

e m

orta

lity

(%)

Medical therapy Medical therapy + ICD

p=0.06

AHA 2003



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



Clinical practiceI 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



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."

Prystowsky

Documents

EP Show – Dec 2003 ICDs – Primary prevention The EP Show: Guidelines and reimbursement at the crossroads: Primary prevention with ICDs Eric Prystowsky