DRAFT
To the
Director of
Regional (National) Health Care Services
cc To:
Regional
(National) President of the Electrophysiology Society
cc To:
Regional
(National) President of the Cardiology Society
Since some
years a new methodology for risk assessment of sudden death is available in
USA. This methodology, Micro T Wave Alternans (MTWA), is the only non-invasive
method approved by Food and Drug Administration (FDA) (1) for risk assessment
of sudden death in patients with known , suspected or at risk of ventricular
arrhythmia.
This
methodology has Sensitivity and Specificity similar to the invasive
Electrophysiology Test (EP) but it is ten times less expensive and without any
patient risk (2-9).
Following
the announcement of US MEDICARE of a specific Procedural Code (CPT Code 93095 -
January 1st, 2002) for MTWA test, we kindly ask this authority to approve a
Procedural Code for MTWA for the following clinical and economic reasons:
1) MTWA can be tested in any Hospital because
it is not invasive and can be tested during a standard Cardiologic Stress test
on Ergometer or Treadmill.
2) MTWA has been mentioned by the Sudden Death
Task Force of the European Society of Cardiology as methodology to assess
the risk of Sudden Death.
3) MTWA has been tested in more than 4000
patients with published results and in more that 2000 patients we have the
comparison with the Electrophysiology test and follow up for Sudden Death.
4) MTWA has been tested also in 2 independent
Multicenter Clinical Trails in USA (9 centres, 350 patients, JACC 2000;36 N.7)
and in Japan (7 Centres, 830 patients, The American Journal of Cardiology Vol
89 January 1, 2002) (1-6.19,21-23,26-28) with concordant results.
5) In these papers the Negative Predictive
Value is better than EP test and therefore it can be used as screening in
population at risk or in patients where no methodology has been used as in the
non-ischemic dilated cardiomyopathy patient (21-23)
6) In some University Hospitals in Europe and
in USA this methodology is now used routinely to assess the risk in patients
admitted for Syncope.
In this type of patients there are ( in Italy) about 32.000 admission per year with a total number of 183.000 days of hospitalisation. This means (at a cost of about 1000 Euros per day) 180 Million Euros per year.
Due to the fact that in all the clinical trails (including 2000 patients) the negative predictive value is near 99% (almost no patient having the MTWA test negative had sudden death in the following 15 months) it is worth to hospitalise only the patients with positive MTWA test with a money saving of more than 100 Million Euros per year (per country) because about 65% will have a negative test.
The patients negative to MTWA can be tested with
other ambulatory tests ( Holter, event recorders etc.)
In
addition a new clinical trail called MADIT II suggests that a Implantable
Defibrillator should be implanted in all patients after Myocardial infarction
with Ejection fraction lower that 30%. This will increase dramatically the
Health Care costs.
To
reduce these exponential increases in costs we suggest to stratify further the
risk with MTWA because from the study published on The Lancet (August 2000) in
the same population no patient having MTWA negative had arrhythmic events in
the following 24 months and therefore there is no need to implant a
defibrillator.
In Conclusion: MTWA should be included as Ambulatory
Procedure with a specific Procedural Code together with the Stress Test. This
will decrease the actual Health Care Costs of
more than 100 Million Euros and will provide a limitation of the forecasted
increase of costs due to the application of the MADIT II trail.
We would like the opinion of the experts in
arrhythmology and cardiology on the matter and we are at your disposal for any
additional information.
Best regards
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