Methods for identifying patients at risk for life threatening arrhythmias

• US 7,622,303 B2
• Filed: 02/03/2005
• Issued: 11/24/2009
• Est. Priority Date: 02/05/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Soykan, Orhan, Sharma, Vinod, Olson, Walter H., Dearking, Amy C., Robinson, Timothy H.
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US11/050,611
• Publication Number:
  US 20050177196A1
• Time in Patent Office: 1,755 Days
• Field of Search: 436/56, 435/69.1, 435/366, 435/320.1
• US Class Current: 436/56
• CPC Class Codes: G01N 2800/326 Arrhythmias, e.g. ventricular fibrillation, tachycardia, atrioventricular block, torsade de pointes
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10T 436/13 Tracers or tags

Abstract

In general, the invention is directed to systems and techniques for assessing a risk of ventricular tachyarrhythmia in a patient by measuring one or more biochemical markers that reflect the health of a patient. Typically, the patient submits a sample, such as a blood sample, which is tested for one or more biomarkers. Based upon the results of the tests, the patient'"'"'s risk of ventricular tachyarrhythmia may be assessed. When the patient is found to be at risk, the patient may receive an implantable medical device or drug therapy to address the risk.

Claims

1. A method for assessing a risk of ventricular tachyarrhythmia in a patient using a plurality of biochemical markers, comprising the steps of:

assessing the risk of ventricular tachyarrhythmia in the patient as a function of a measurement of a first biochemical marker A in the patient;

assessing the risk of ventricular tachyarrhythmia as a function of a measurement of a second biochemical marker B in the patient;

comparing a measure M_A of the first biochemical marker A to a threshold value T_A of A, wherein if M_A is greater than or equal to T_A, a risk of ventricular tachyarrhythmia does not exist in a patient, and wherein if M_A is less than T_A, a risk of ventricular tachyarrhythmia may or may not exist in said patient, and wherein if M_A is less than T_A, comparing a measure M_B of the second biochemical marker B to a threshold value T_B of B, wherein if M_B is less than T_B a risk of ventricular tachyarrhythmia does not exist in the patient, and wherein if M_B is greater than or equal to T_B, a risk of ventricular tachyarrhythmia may or may not exist in the patient.

2. The method according to claim 1, wherein a benefit of administering a drug to the patient as a function of the measurement of the biochemical markers is assessed.

3. The method according to claim 1, wherein assessing the risk of ventricular tachyarrhythmia comprises one of generating a sorting tree, generating a logical test, generating an artificial neural network, and assessing the risk of at least one of ventricular tachycardia, ventricular fibrillation, and sudden cardiac death.

4. The method according to claim 1, wherein measuring the biochemical markers comprises one of measuring a mass of the biochemical markers, measuring a mass-to-charge ratio of the biochemical marker with a mass spectrometer, and measuring an isoelectric pH of the biochemical markers.

5. The method according to claim 1, wherein the biochemical markers comprises one of a protein, a lipid and a gene.

6. The method according to claim 1, further comprising:

measuring a physiological factor of the patient; and

assessing the risk of ventricular tachyarrhythmia in the patient as a function of the measurement of the physiological factor.

7. The method according to claim 6, wherein the physiological factor comprises at least one of an electrophysiological factor and a hemodynamic factor.

8. The method according to claim 1, further comprising one of assessing a benefit of implanting a medical device in the patient as a function of the measurements, and assessing a benefit of administering an antiarrhythmic drug to the patient as a function of the measurements.

9. The method according to claim 8, wherein the medical device comprises at least one of an electronic cardiac stimulation device and a drug delivery device.

10. The method according to claim 1, further comprising:

exposing a biochip to a biological sample from a patient, the biochip comprising a plurality of sensing elements; and

assessing the risk of ventricular tachyarrhythmia in the patient as a function of a reaction between the sample and the sensing elements.

11. The method of claim 10, wherein assessing the risk of ventricular tachyarrhythmia in the patient as a function of a reaction between the sample and the sensing elements comprises performing mass spectrometry on the biochip.

12. The method of claim 11, wherein performing the mass spectroscopy comprises performing a Surface Enhanced Laser Desorption/Ionization process.

13. The method of claim 1, wherein measuring the biochemical markers comprises one of determining one of the presence and the absence of the biochemical markers, and determining a change of concentration of the biochemical markers.

14. The method of claim 1, further comprising applying a therapy as a function of the assessment.

15. The method of claim 14, wherein applying a therapy comprises one of implanting an electronic cardiac stimulation device in the patient, administering an antiarrhythmic drug to the patient, and determining at least one of a protein and a gene to be delivered to the patient.

16. The method of claim 1, wherein if M_B is greater than or equal to T_B, further comprising the step of:

comparing a measure M_C of a biochemical marker C to a threshold value T_C of C, wherein if M_C is less than T_C, a risk of ventricular tachyarrhythmia does not exist in the patient, and wherein if M_C is greater than or equal to T_C, a risk of ventricular tachyarrhythmia may or may not exist in the patient.

17. The method of claim 1, wherein if M_A is greater than or equal to T_A, further comprising the step of:

comparing a measure M_D of a biochemical marker D to a threshold value T_D of D, wherein if M_D is less than T_D, a risk of ventricular tachyarrhythmia does not exist in the patient, and wherein if M_D is greater than or equal to T_D, a risk of ventricular tachyarrhythmia may or may not exist in the patient.

18. The method of claim 17, wherein if M_D is greater than or equal to T_D, further comprising the step of:

comparing a measure M_C of a biochemical marker C to a threshold value T_C of C, wherein if M_C is less than T_C, a risk of ventricular tachyarrhythmia does not exist in the patient, and wherein if M_C is greater than or equal to T_C, a risk of ventricular tachyarrhythmia may or may not exist in the patient.

19. The method of claim 1, further comprising the step of:

comparing a plurality of biochemical biomarkers P1, P2, P3 and P4 in a patient, wherein

P1 is a protein having a Molecular Weight (Da) of 10,146.5 and an Isoelectric pH (pI) of 9+ and a Capture Surface of a weak cation exchange (CM

     10),

P2 is a protein having a Molecular Weight (Da) of 15,006 and an Isoelectric pH (pI) of 9+ and a Capture Surface of a weak cation exchange (CM

     10),

P3 is a protein having a Molecular Weight (Da) of 166,582 and an Isoelectric pH (pI) of 5-7 and a Capture Surface of a weak cation exchange (CM

     10), and

P4 is a protein having a Molecular Weight (Da) of 10,948 and an Isoelectric pH (pI) of 9+ and a Capture Surface of an Immobilized Ion Affinity Surface (IMAC).

20. The method of claim 19, further comprising the step of:

evaluating in the patient an amount of P1 where if P1 is greater than or equal to 1.0422237 in arbitrary units, the patient is not at significant risk of ventricular tachyarrhythmia, and where if P1 is less than 1.0422237, the patient may be at risk of ventricular tachyarrhythmia.

21. The method of claim 20, further comprising the step of:

evaluating in the patient an amount of P2 where if P2 is greater than or equal to 0.2306074 in arbitrary units, the patient may be at significant risk of ventricular tachyarrhythmia, and where if P2 is less than 0.2306074, the patient is not at risk of ventricular tachyarrhythmia.

22. The method of claim 21, further comprising the step of:

evaluating in the patient an amount of P3 where if P3 is greater than or equal to 0.049 1938 in arbitrary units, the patient is not at significant risk of ventricular tachyarrhythmia, and where if P3 is less than 0.049 1938, the patient may be at risk of ventricular tachyarrhythmia.

23. The method of claim 22, further comprising the step of:

evaluating in the patient an amount of P4 where if P4 is greater than or equal to 0.027011 in arbitrary units, the patient is a candidate for an Implantable Medical Device, and where if P4 is less than 0.027011, the patient is not a candidate for an Implantable Medical Device.

24. The method according to claim 1, wherein a benefit of implanting a medical device in the patient as a function of the measurement of the biochemical markers is assessed.