IP Library › Granted Patent US 11,340,236
Granted Patent B2
US 11,340,236 · App. 16/563,510 · Granted May 24, 2022

Methods for treating or predicting risk of a ventricular tachyarrhythmia event

Inventors: James V. Snider (San Diego, CA); Timothy Edward Meyer (North Oaks, MN); Craig Michael Stolen (New Brighton, MN); Robert W. Gerwien (Newington, CT)
Assignees: Critical Care Diagnostics, Inc.; Cardiac Pacemakers, Inc.
G01N33/6887A61B5/7275A61N1/3627G01N33/6893A61N1/3956G01N2333/7155G01N2800/325G01N2800/326G01N2800/50
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Quick Facts
Patent No.
US 11,340,236
App. No.
16/563,510
Granted
May 24, 2022
Kind
B2
Abstract

Provided herein are methods that include (i) determining a level of soluble ST2 in a biological sample from a subject, (i) comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2 (e.g., a level of soluble ST2 in the subject at an earlier time point), and (iii) selecting, implanting, replacing, or reprogramming an implanted cardiac device, e.g., an ICD, CRT, or CRT-D device, for a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2, or selecting a subject for participation in, or stratifying a subject participating in, a clinical study of a treatment for reducing the risk of a ventricular tachyarrhythmia (VTA) event. Also provided are methods for evaluating the risk of a VTA event in a subject. Also provided are kits for performing any of these methods.

Claims (24)

1. A method for selecting a treatment for a subject having heart failure to reduce the risk of a ventricular tachyarrhythmia (VTA) event, the method comprising:

determining a first level of soluble ST2 in a biological sample comprising blood, serum or plasma obtained from a subject having heart failure at a first time point;

determining a second level of soluble ST2 in a biological sample comprising blood, serum or plasma obtained from the subject at a second time point;

identifying a subject having an elevated second level of soluble ST2 as compared to the first level of soluble ST2 as being more likely to benefit from implantation of an implantable cardiac defibrillator (ICD), a cardiac resynchronization therapy device (CRT), or a combination cardiac resynchronization therapy defibrillator device (CRT-D); and

selecting an ICD, a CRT, or a CRT-D for the identified subject.

2. The method of claim 1 , wherein the subject has previously had at least one ventricular tachyarrhythmia event.

3. The method of claim 1 , wherein the method comprises selecting an ICD for the identified subject.

4. The method of claim 1 , wherein the method comprises selecting a CRT for the identified subject.

5. The method of claim 1 , wherein the method comprises selecting a CRT-D for the identified subject.

6. A method of treating a subject having heart failure to reduce the risk of a ventricular tachyarrhythmia (VTA) event, the method comprising:

determining a first level of soluble ST2 in a biological sample comprising blood, serum, or plasma from a subject having heart failure;

determining a second level of soluble ST2 in a biological sample comprising blood, serum, or plasma from the subject;

identifying a subject having an elevated second level of soluble ST2 in the biological sample compared to the first level of soluble ST2 as being more likely to benefit from implantation of an implantable cardiac defibrillator (ICD), a cardiac resynchronization therapy device (CRT), or a combination cardiac resynchronization therapy defibrillator device (CRT-D); and

implanting an ICD, a CRT, or a CRT-D device into the identified subject, or replacing or reprogramming an implanted ICD, CRT, or CRT-D in the identified subject.

7. The method of claim 6 , wherein the subject has previously had at least one ventricular tachyarrhythmia event.

8. The method of claim 6 , wherein the method comprises implanting an ICD into the identified subject.

9. The method of claim 6 , wherein the method comprises implanting a CRT into the identified subject.

10. The method of claim 6 , wherein the method comprises implanting a CRT-D into the identified subject.

11. The method of claim 6 , wherein the method comprises replacing an implanted ICD in the identified subject.

12. The method of claim 6 , wherein the method comprises replacing an implanted CRT in the identified subject.

13. The method of claim 6 , wherein the method comprises replacing an implanted CRT-D in the identified subject.

14. The method of claim 6 , wherein the method comprises reprogramming an implanted ICD in the identified subject.

15. The method of claim 6 , wherein the method comprises reprogramming an implanted CRT in the identified subject.

16. The method of claim 6 , wherein the method comprises reprogramming an implanted CRT-D in the identified subject.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY ADDRESS PREVIOUSLY RECORDED AT REEL: 50511 FRAME: 312. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Oct 7, 2019
From: MEYER, TIMOTHY EDWARD; STOLEN, CRAIG MICHAEL
To: CARDIAC PACEMAKERS, INC.
Reel/Frame 050642/0239 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2019
From: MEYER, TIMOTHY EDWARD; STOLEN, CRAIG MICHAEL
To: CARDIAC PACEMAKERS, INC.
Reel/Frame 050511/0312 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2019
From: SNIDER, JAMES V.; GERWIEN, ROBERT W.
To: CRITICAL CARE DIAGNOSTICS, INC
Reel/Frame 050511/0515 →
Continuity (4)
Continuation 15370049 · Dec 6, 2016
Continuation 13897249 · May 17, 2013
Provisional Application 61649202 · May 18, 2012
Related Publication 20190391162A1 · Dec 26, 2019