Method for optimizing CRT therapy

Abstract

A method to optimize CRT therapy using ventricular lead motion analysis, either radiographically or with three dimensional electromagnetic mapping, to determine whether focal dyssynchrony is present at baseline, and whether biventricular pacing improves synchronicity and fractional shortening, and if no improvement is evidenced, changing the timing offset, pacing configuration and/or repositioning the ventricular leads to optimize effectiveness of CRT therapy. Various uses of this method include: diagnostic, with temporary leads to determine presence or absence of dyssynchrony and response to pacing; and therapeutic, to guide lead placement and programming during implant of CRT, and to optimize reprogramming of CRT during follow-up.

What we claim is: 
     
       1. A method for determining and optimizing left ventricular synchrony during cardiac resynchronization therapy comprising in combination:
 identifying a patient as having perceived ventricular systolic dyssynchrony who may benefit from cardiac resynchronization therapy; 
 implanting left ventricular and right ventricular leads in the patient's heart, each lead having a lead tip at a first end portion; 
 positioning each lead tip initially at a location prior published studies have shown generate the greatest physiologic benefit from pacing; 
 connecting a pacemaker to the plural leads opposite the lead tips; 
 using a radiographic imaging system to make cine loop image recordings of the patient's heart in left anterior oblique, right anterior oblique and anterior-posterior views through at least three complete cardiac cycles during intrinsic heart rhythm and assigning time stamps to each cine frame to ascertain the position of each lead tip throughout the intrinsic cardiac cycles; 
 transferring the intrinsic rhythm cine loop image recordings to an image compiling system for compiling into intrinsic heart rhythm data and for determining an X-axis, a Y-axis and a Z-axis coordinate for each lead tip for each time stamped cine frame; 
 transferring the X-axis, the Y-axis and the Z-axis coordinate for each lead tip for each intrinsic rhythm time stamped cine frame to an analytical software program to determine a baseline measure of dyssynchrony and contractility at the current lead tip locations in the patient's heart; 
 activating the pacemaker to send electrical pacing impulses through the ventricular leads to the lead tips for paced activation of the patient's heart; 
 using the radiographic imaging system to make cine loop image recordings of the heart in left anterior oblique, right anterior oblique and anterior-posterior views through at least three complete cardiac cycles during the paced heart rhythm and assigning time stamps to each cine frame to ascertain the position of each lead tip throughout the paced cardiac cycles; 
 transferring the paced rhythm cine loop image recordings to the image compiling system for compiling into paced heart rhythm data and for determining the X-axis, Y-axis and Z-axis coordinate for each lead tip for each paced time stamped cine frame; 
 transferring the X-axis, the Y-axis and the Z-axis coordinate for each lead tip for each paced rhythm time stamped cine frame to the analytical software program to determine a measure of paced ventricular dyssynchrony and paced ventricular contractility at the current lead tip locations in the patient's heart; 
 plotting the intrinsic heart rhythm coordinate data and plotting the paced heart rhythm coordinate data and generating a visual display showing the motion of the lead tips by time so that the intrinsic heart rhythm coordinate data may be compared against the paced heart rhythm coordinate data; 
 interpreting the intrinsic heart rhythm coordinate data and the paced heart rhythm coordinate data to determine if the paced activation of the patient's heart decreases the ventricular dyssynchrony relative to the intrinsic ventricular dyssynchrony and increases ventricular contractility relative to the intrinsic contractility; and 
 ending the cardiac resynchronization therapy if the interpretation of the paced heart rhythm data compared against the intrinsic heart rhythm data shows increased contractility and increased synchrony with paced activation of the patient's heart at the current lead tip locations. 
 
     
     
       2. The method for determining and optimizing left ventricular synchrony of  claim 1  wherein a right ventricular lead tip is located on the patient's heart's right ventricular septum. 
     
     
       3. The method for determining and optimizing left ventricular synchrony of  claim 1  wherein a right ventricular lead tip is located on the patient's heart's right ventricular apex. 
     
     
       4. The method for determining and optimizing left ventricular synchrony of  claim 1  wherein: a left ventricular lead tip is located on a left ventricular lateral wall. 
     
     
       5. The method for determining and optimizing left ventricular synchrony of  claim 1  wherein: a left ventricular lead tip is located on a left ventricular anterolateral wall. 
     
     
       6. The method for determining and optimizing left ventricular synchrony of  claim 1  wherein: a left ventricular lead tip is located on a left ventricular posterolateral branch of the coronary sinus. 
     
     
       7. The method for determining and optimizing left ventricular synchrony of  claim 1  further comprising:
 if interpretation of the results shows no improvement in contractility and no improvement in synchrony, documenting the position of the lead tips in the heart; 
 changing the position of at least one lead tip; and 
 repeating the steps of  claim 1  for activating the pacemaker, imaging, compiling, identifying coordinate positions and comparing the paced heart rhythm data against the intrinsic heart rhythm data. 
 
     
     
       8. The method for determining and optimizing left ventricular synchrony of  claim 1  further comprising:
 if interpretation of the results shows minimal improvement in contractility and minimal improvement in synchrony, documenting the position of the lead tips in the heart; 
 changing the position of at least one lead tip; and 
 repeating the steps of  claim 1  for activating the pacemaker, imaging, compiling, identifying coordinate positions and comparing the paced heart rhythm data against the intrinsic heart rhythm data. 
 
     
     
       9. The method for determining and optimizing left ventricular synchrony of  claim 1  further comprising:
 if interpretation of the results shows minimal improvement in contractility and minimal improvement in synchrony, documenting the position of the lead tips in the heart; 
 changing the pacing configuration; and 
 repeating the steps of  claim 1  for activating the pacemaker, imaging, compiling, identifying coordinate positions and comparing the paced heart rhythm data against the intrinsic heart rhythm data. 
 
     
     
       10. The method for determining and optimizing left ventricular synchrony of  claim 1  further comprising:
 if interpretation of the results shows minimal improvement in contractility and minimal improvement in synchrony, documenting the position of the lead tips in the heart; 
 changing the ventricular pacing offsets; and 
 repeating the steps of  claim 1  for activating the pacemaker, imaging, compiling, identifying coordinate positions and comparing the paced heart rhythm data against the intrinsic heart rhythm data. 
 
     
     
       11. The method for determining and optimizing left ventricular synchrony of  claim 1  further comprising:
 if interpretation of the results shows minimal improvement in contractility and minimal improvement in synchrony, documenting the position of the lead tips in the heart; 
 changing the timing of the electrical impulses; and 
 repeating the steps of  claim 1  for imaging, compiling, identifying coordinate positions and comparing the paced heart rhythm data against the intrinsic heart rhythm data. 
 
     
     
       12. The method for determining and optimizing left ventricular synchrony of  claim 1  further comprising wherein:
 using a three dimensional mapping system is used to generate a three dimensional lead tip motion assessment without instead of X-ray to avoid the detrimental effects of X-ray exposure to provide ability to determine electromechanical measurements related to dyssynchrony. 
 
     
     
       13. The method for determining and optimizing left ventricular synchrony of claim  1  wherein 12 further comprising:
 the method is utilized during routine follow-up care of patients having previously undergone cardiac resynchronization therapy; using plural topical heart monitor patches to provide three dimensional analysis and the present method to provide lead tip motion analysis during office reprogramming of the pacemaker to maximize long term benefits of cardiac resynchronization therapy. 
 
     
     
       14. The method for determining and optimizing left ventricular synchrony of claim  1  12 wherein:
 three-dimensional lead tip motion analysis is performed using simultaneous bi-plane imaging in left anterior oblique and right anterior oblique imaging views; 
 the left anterior oblique view is adjusted to represent short axis of the left ventricle to show radial shortening; 
 the right anterior oblique view is obtained at a 90° angle; 
 simultaneous cine is performed in the two views; 
 the left ventricular lead tip motion data is plotted to determine short axis movement (X and Y axis) and right ventricular lead tip motion data is plotted to obtain longitudinal motion (Z axis); 
 using the X, Y and Z axis coordinates, three-dimensional left ventricular lead tip motion and three dimensional right ventricular lead tip motion is determined without the detrimental effects of x-ray to determine left ventricular lead tip motion and right ventricular lead tip motion to graph and analyze dyssynchrony and, fractional shortening, and heart wall movement. 
 
     
     
       15. The method for determining and optimizing left ventricular synchrony of claim  1  12 wherein:
 three-dimensional lead tip motion analysis is obtained using plural topical patches applied to the patient's chest using a global positioning approach to document the ventricular lead tip positions by time; 
 data is collected using the right ventricular one lead tip as a reference and the left ventricular a second lead tip as input during intrinsic ventricular rhythm and various configurations of paced ventricular rhythm; 
 lead tip motion is documented during intrinsic heart rhythm and during the paced biventricular rhythm including assessing right and left ventricular pacing offsets, paced right ventricular rhythm and paced left ventricular rhythm, at differing right and left ventricular lead locations and differing pacing configurations; and 
 simultaneous ECG input provides electromechanical measurements of timing from QRS onset to peak mechanical contraction of left and right ventricles during intrinsic and paced rhythms. 
 
     
     
       16. The method for determining and optimizing left ventricular synchrony of  claim 1  wherein:
 the patient is identified as a candidate for cardiac resynchronization therapy by diagnostic use of the method using temporary pacing catheters in the right ventricle and coronary sinus to assess for baseline dyssynchrony and to predict potential response to cardiac resynchronization therapy. 
 
     
     
       17. The method for determining and optimizing left ventricular synchrony of  claim 1  wherein:
 the cine is not less than 15 frames per second and time stamps are recorded on each cine frame. 
 
     
     
       18. A method for determining and optimizing ventricular heart wall motion in a patient having ventricular heart wall movement dysfunction comprising in combination:
 identifying a patient as having perceived ventricular heart wall movement dysfunction who may benefit from therapy;   placing pacing leads having electrodes at a lead tip end portion in the patient's heart;   positioning each lead initially at a location published studies have shown to generate physiologic benefit from pacing;   using radiographic imaging to make recordings of the heart in multiple views through plural complete cardiac cycles including systole and diastole during intrinsic heart rhythm and assigning a time stamp to ascertain the position of a lead throughout the cardiac cycles including systole and diastole;   determining an X-axis, a Y-axis, and a Z-axis coordinate for the lead position for the time stamp;   compiling the intrinsic heart rhythm data;   analyzing the compiled intrinsic heart rhythm data to determine a baseline measure of dyssynchrony contractility and/or ventricular heart wall motion through the plural complete cardiac cycles including systole and diastole;   applying an electrical signal to the leads to pace the heart;   using radiographic imaging to make recordings of the heart in multiple views through plural complete cardiac cycles including systole and diastole during paced heart rhythm and assigning a time stamp to ascertain the position of each lead throughout the plural complete cardiac cycles including systole and diastole;   determining an X-axis, a Y-axis, and a Z-axis coordinate for each lead position for each time stamp;   compiling the paced heart rhythm data;   analyzing the compiled paced heart rhythm data to determine a measure of dyssynchrony and contractility through plural complete cardiac cycles including systole and diastole;   comparing the intrinsic heart rhythm data and the paced heart rhythm data and generating a visual display showing the motion of the leads throughout the plural complete cardiac cycles by time;   interpreting the intrinsic heart rhythm data and the paced heart rhythm data to determine if there is an improvement in dyssynchrony, contractility or ventricular heart wall movement throughout the plural complete cardiac cycles resulting from pacing;   if interpretation of the paced heart rhythm data shows no improvement or minimal improvement in synchrony, contractility, or or ventricular heart wall movement, documenting the position of the lead tips in the heart;   changing the pacing configurations, and/or changing a lead tip position and repeating the imaging, compiling, identifying coordinate positions, and comparing the paced heart rhythm data and intrinsic heart rhythm data; and   ending the procedure if assessment of the paced heart rhythm data shows improvement in synchrony, contractility, or ventricular heart wall movement.   
     
     
       19. The method for determining and optimizing ventricular heart wall motion of claim 18 further comprising:
 simultaneous electrocardiographic (ECG) monitoring to determine electromechanical and mechanical measurements of ventricular heart wall movement, electrical depolarization and re-polarization throughout the plural complete cardiac cycles, rates of systolic and diastolic ventricular wall motion, duration of systole and diastole, during intrinsic and paced rhythm, for diagnostic assessment of systolic and diastolic heart failure, and to guide therapy.   
     
     
       20. A method for determining and optimizing ventricular heart wall motion in a patient having ventricular heart wall movement dysfunction comprising in combination:
 identifying a patient as having perceived ventricular heart wall movement dysfunction who may benefit from therapy;   placing pacing leads having electrodes at a lead tip end portion in the patient's heart;   positioning each lead initially at a location published studies have shown to generate physiologic benefit from pacing;   using three dimensional imaging to make recordings of the lead electrodes movement through plural complete cardiac cycles including systole and diastole during intrinsic heart rhythm and assigning a time stamp to ascertain the position of each electrode throughout the cardiac cycles;   determining an X-axis, a Y-axis, and a Z-axis coordinate for each electrode position for the time stamps;   compiling the intrinsic heart rhythm data;   analyzing the compiled intrinsic heart rhythm data to determine a baseline measure of dyssynchrony, contractility and ventricular heart wall motion throughout the plural complete cardiac cycles including systole and diastole;   applying an electrical stimulus to the leads to pace the heart;   using three dimensional imaging to make recordings of the lead electrodes movement through plural complete cardiac cycles including systole and diastole during paced heart rhythm and assigning a time stamp to ascertain the position of each electrode position throughout the plural complete cardiac cycles;   determining an X-axis, a Y-axis, and a Z-axis coordinate for each electrode position for the time stamps;   compiling the paced heart rhythm data;   analyzing the compiled paced heart rhythm data to determine a measure of dyssynchrony, contractility and ventricular heart wall motion throughout the plural complete cardiac cycles including systole and diastole;   comparing the intrinsic heart rhythm data and the paced heart rhythm data and generating a visual display showing the motion of the lead throughout the plural complete cardiac cycles by time;   interpreting the intrinsic heart rhythm data and the paced heart rhythm data to determine if there is improvement in dyssynchrony, contractility and ventricular heart wall motion throughout the plural complete cardiac resulting from the pacing; and   if interpretation of the intrinsic heart rhythm data and the paced heart rhythm data shows no/minimal improvement in synchrony, contractility, or ventricular heart wall movement, documenting the position of the leads in the heart;   changing the lead position and/or changing a pacing configuration and/or changing ventricular pacing offsets; and   repeating the steps of claim 20 for imaging, compiling, identifying coordinate positions, and comparing the intrinsic heart rhythm data and the paced heart rhythm data; and   ending the procedure if assessment of the results shows improvement in synchrony, contractility, or ventricular heart wall movement.   
     
     
       21. The method for determining and optimizing ventricular heart wall motion of claim 20 wherein: one lead is positioned in the patient's right ventricle to optimize ventricular synchrony, ventricular contractility, and/or ventricular heart wall motion. 
     
     
       22. The method for determining and optimizing ventricular heart wall motion of claim 20 wherein: one lead is positioned in the patient's coronary venous system to optimize ventricular synchrony, ventricular contractility, and/or ventricular heart wall motion. 
     
     
       23. The method for determining and optimizing ventricular heart wall motion of claim 20 wherein: one lead is positioned on the patient's left ventricular epicardium to optimize ventricular synchrony, ventricular contractility, and/or ventricular heart wall motion. 
     
     
       24. The method for determining and optimizing ventricular heart wall motion of claim 20 further comprising:
 simultaneous ECG to determine electromechanical and mechanical measurements of ventricular heart wall movement related to dyssynchrony, contractility, and electrical depolarization and repolarization ventricular heart wall motion throughout the plural complete cardiac cycles, as a diagnostic tool during lead implant and during cardiac resynchronization therapy follow up.   
     
     
       25. The method for determining and optimizing ventricular heart wall motion of claim 20 further comprising:
 simultaneous electrocardiographic (ECG) monitoring to determine electromechanical and mechanical measurements of contraction and ventricular heart wall motion including electrical depolarization and re-polarization throughout the plural complete cardiac cycles, rates of systolic and diastolic ventricular heart wall motion and relative duration of systole and diastole during intrinsic and paced rhythm for diagnostic assessment of systolic and diastolic heart failure to guide therapy.