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



Subject: Proposal for hospitalisation costs / timing reduction in case of admission for Syncope and limitation of Health Care costs.


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






1)           T wave alternans: predictive value of  T wave alternans in sudden cardiac death.Compendium compiled for FDA by Cambridge Heart. MA  USA 1999 1-135

2)           Rosenbaum D, Lance J, Smith J,  et al Electrical Alternans and Vulnerabilità to Ventricular Arrhythmias. New england Journal of Medicine 330:235-241 (January 27), 1994

3)           MR. Gold, N El Sherif. New Insights into arrhythmogenesis and use of T wave alternans for  risk assessment. ACC 1998.

4)           O. Scwab et al. Incidence of T wave alternans after acute myocardial infarction and correlation with other prognostic parameters : results of a prospective study. PACE 2001; 957-961

5)           JP. Di Marco. Editorial comment.  Is programmed electrical stimulation in survivors of myocardial infarction helpful ? JACC 2001; 37: 7 1908-1909

6)           C Smith et al . Value of programmed ventricular stimulation for prophylactic internal cardioverter defibrillator implantation in post infarction patients preselected by non invasive risk stratifier. JACC 2001; 37:1901-1907

7)           L Jordaens et al. Determinants od sudden death, after discharge from hospital for myocardial infarction in the thrombolytic era. The MIRRACLE investigators.  Eur Heart J 2001; 22: 1214-1225

8)           S. Priori et al. Task Force on sudden death of the European Society of Cardiology. European Heart Journal 2001;222:1374-1450.

9)           F. Naccarella et al.  Arrhythmic risk stratification of post myocardial infarction patients. Curr Opin Cardiol 2000; 15: 1-6.

10)         RNW. Hauer et al. Indications for implantable cardioverter defibrillator  (ICD) therapy. European Heart Journal  2001; 22: 1074-1081

11)         M. Brignole, P. Alboni et al. Guideliness on managment (diagnosis and treatment) of syncope. European Heart Journal 2001; 22: 1256-1306

12)         S. Mittal et al. Significance of inducible ventricular fibrillation in patients with coronary artery disease and unexsplained syncope. JACC 2001; 38: 371-376

13)         S. Mittal  et al. Long Term outcome of patients with unexsplained syncope treated  with an electrophysiologic –guided approach in the implantable cardioverter defibrillator era.   JACC 1999 ; 34 : 1082-9.

14)         JS. Steinberg et al. Follow up of patients with unexsplained syncope and inducible ventricular tachyarrhythmias : analysis of the AVID registry and an AVID substudy. J Cardiovascular Electrophysiol 2001; 12: 996-1001.

15)         A. Mosterd et al. The prognosis of heart failure in the general population The Rotterdam study, European Heart Journal 2001 ; 22 : 1318-1327.

16)         MO Sweeney. Sudden cardiac death in heart failure associated with reduced left ventricular function: substrates mechanisms and evidence based management Part II. PACE 2001;24: 871-888.

17)         F. Naccarella et al. Proarrhythmic events and drug induced QT prolongation and torsades de pointes due to old and new antiarrhythmic drugs and no antiarrhythmic drugs. MESPE Journal 2000; 4:173-186.

18)         Adachi K, Ohnishi Y, Shima T, et al. :Determinant of microvolt-level T wave Alternans in patients with dilateted cardiomiopathy;JACC 1999 Aug: 34(2):374-80

19)         Klingenhaben T, Hohnloser S et al. Predictive Value of T Wave Alternans in Patients with Congestive Heart Failure. The Lancet 2000; 356: 651-52

20)         Gold MR; Bloomfield DM; Anderson KP. A Comparison of T wave Alternans, Signal Averaged ECG and Programmed Ventricular Stimulation for Arrhythmia Risk Stratification. JACC 2000;36:2247-53

21)         Sakebe K et al. Predicting the Reoccurence of Ventricular Tachyarrhythmias from T Wave Alternans Assessed on Antiarrhythmic Pharmacotheraphy. A.N.E. 2001; 6(3): 203-208

22)         MADIT II. Final results. Late breaking clinical trials AHA 12/11/2001 Anaheim.

23)         Bloomfield DM, Gold MR, Anderson KP, et al. T Wave Alternans Predicts Events in Patients with Syncope Undergoing Electrophysiology Testing. Circulation 1999; 100: I-508

24)         T. Ikeda et al  T wave Alternans as a Predictor for Sudden Cardiac Death After Myocardial Infarction. The American Journal of Cradiology Vol 89 January 1, 2002

25)         Kitamura H, et al Onset Heart Rate of MicroVolt Level T Wave Alternans Provides Clinical and Prognostic Value in Nonischemic Dilated Cardiomiopathy. JACC 2002; 39:295-300