Methods for the treatment of cardiovascular conditions

• US 9,198,908 B2
• Filed: 03/17/2014
• Issued: 12/01/2015
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Luxembourg Holdings Ii S.A.R.L.
• Original Assignee: St. Jude Medical Luxembourg Holdings Ii S.A.R.L.
• Inventors: Yadav, Jay
• Primary Examiner(s): SHIAO, REI TSANG
• Application Number:
  US14/216,582
• Publication Number:
  US 20140288085A1
• Time in Patent Office: 624 Days
• Field of Search: 514/250, 514/252
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61K 31/4985 Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings

Abstract

Provided herein are methods and systems for the treatment of cardiovascular conditions, including pulmonary hypertension (PH), in subjects that are being treated with a treatment regimen that includes a phosphodiesterase-5 (PDE-5) inhibitor.

Claims

1. A method for treating a subject having a cardiovascular condition, comprising:

(a) administering to the subject a treatment regimen that includes a PDE-5 inhibitor, wherein the PDE-5 inhibitor is selected from tadalafil or sildenafil;

(b) obtaining one or more pulmonary arterial (PA) hemodynamic readings from the subject using an implantable pressure sensor, wherein the PA hemodynamic readings comprise a PA hemodynamic waveform;

(c) processing the PA hemodynamic waveform using the processor of a computing device to obtain a cardiovascular parameter, wherein the cardiovascular parameter is selected from the group consisting of pulmonary arterial pressure (PAP), cardiac output (CO), peripheral vascular resistance (PVR), total peripheral resistance (TPR), heart rate, respiratory rate, dicrotic notch information, or combinations thereof;

(d) comparing the cardiovascular parameter obtained from the subject to a standard to determine the efficacy of the treatment regimen for the treatment of the cardiovascular condition in the subject; and

(e) maintaining or altering the treatment regimen administered to the subject in view of the indicated efficacy of the treatment regimen for the treatment of the cardiovascular condition in the subject.

2. The method of claim 1, wherein the cardiovascular condition comprises pulmonary hypertension.

3. The method of claim 2, wherein the pulmonary hypertension is associated with left heart disease.

4. The method of claim 2, wherein the pulmonary hypertension is associated with right heart disease.

5. The method of claim 1, wherein the standard comprises a cardiovascular parameter previously determined from the subject.

6. The method of claim 5, wherein the standard comprises a plurality of cardiovascular parameters previously determined from the subject.

7. The method of claim 5, wherein the standard comprises a trend in a cardiovascular parameter in the subject.

8. The method of claim 1, wherein the standard comprises a clinically relevant target cardiovascular parameter for the subject.

9. The method of claim 1, wherein the standard comprises a composite of cardiovascular parameters previously determined from a plurality of subjects.

10. The method of claim 1, wherein the one or more PA hemodynamic readings are remotely obtained.

11. The method of claim 1, wherein the one or more PA hemodynamic readings include ambulatory PA hemodynamic readings.

12. The method of claim 1, wherein the implantable pressure sensor is implanted in a pulmonary artery.

13. The method of claim 1, wherein the implantable pressure sensor lacks percutaneous connections.

14. The method of claim 1, wherein the implantable pressure sensor is energized from an external source.

15. The method of claim 1, wherein the implantable pressure sensor is a passive sensor energized to return pressure readings by an electromagnetic field.

16. The method of claim 1, wherein at least one PA hemodynamic reading is obtained while the subject is exercising.

17. The method of claim 1, wherein at least one PA hemodynamic reading is taken while the subject is asleep.

18. The method of claim 1, wherein the one or more PA hemodynamic readings comprises a high-fidelity PA hemodynamic waveform.

19. The method of claim 1, wherein the cardiovascular parameter is selected from the group consisting of PAP, CO, PVR, TPR, and combinations thereof.

20. The method of claim 1, wherein a decrease in PAP compared to the standard, an increase in CO compared to the standard, a decrease in PVR compared to the standard, or a decrease in TPR compared to the standard indicates efficacy of the treatment regimen for the treatment of the cardiovascular condition in the subject.

21. The method of claim 20, further comprising maintaining the treatment regimen administered to the subject.

22. The method of claim 1, wherein an increase in PAP compared to the standard, a decrease in CO compared to the standard, an increase in PVR compared to the standard, or an increase in TPR compared to the standard indicates substandard efficacy of the treatment regimen for the treatment of the cardiovascular condition in the subject.

23. The method of claim 22, further comprising altering the treatment regimen administered to the subject.

24. The method of claim 23, wherein altering the treatment regimen is selected from the group consisting of modifying the administration protocol of the PDE-5 inhibitor, discontinuing use of the PDE-5 inhibitor, administering an alternative therapeutic agent or regimen, or combinations thereof.