Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
1999-12-22
2003-03-25
Bockelman, Mark (Department: 3762)
Surgery
Diagnostic testing
Cardiovascular
Reexamination Certificate
active
06539249
ABSTRACT:
BACKGROUND OF THE INVENTION
I. Field of the Invention
This invention relates generally to an apparatus and method for assessing effectiveness of changes in therapy on a patient's well-being, and more particularly to the long-term assessment of changes in the mode of pacing of CHF patients on their ability to carry out routine daily activities.
II. Discussion of the Prior Art
When cardiac pacemakers were first introduced, they were used primarily to pace the heart when the normal conduction path from the heart's sinoatrial node to its atrial ventricular node or from the atrial ventricular node to the ventricles was interrupted. The pacemaker was called upon to deliver ventricular stimulating pulses to maintain a predetermined heart beat rate. More recently, pacing has been used to enhance the hemodynamic performance of the heart in patients suffering from congestive heart failure (CHF) or other type of left ventricular dysfunction. It has been found that by pacing the left ventricle and appropriately setting the AV delay parameter of a pacemaker, the patient's cardiac output can be optimized.
To assess the efficacy of changes made in a pacing parameter such as pacing rate or A-V delay interval, inter-ventricular delay, maximum atrial tracking rate, ventricular regularization parameters, etc., it is of interest to monitor the level of activity of the patient over prolonged periods of time in that it is now well recognized that the activity profile of CHF patients is indicative of their well being and prognosis. That is to say, a direct correlation has been found between a CHF patient's level of activity and their overall well-being. Currently, exercise tests and quality of life questionnaires administered at the physician's office determine the patient's status. It is desirable, however, to determine the status of the patient in a natural setting. Among the many exercise tests that have been employed by physicians in assessing the long-term prognosis of CHF patients has been the “six-minute walk” distance. In a paper entitled “Prediction of Mortality and Morbidity with a Six-Minute Walk Test in Patients with Left Ventricular Dysfunction” by Vera Bittner, M.D., et al. and published in the Oct. 13, 1993 edition of the
Journal of the American Medical Association
(Vol. 240, No. 14, pp. 1702-1707) a study is described that was performed to determine the potential usefulness of the six-minute walk test as a prognostic indicator in patients with CHF. Based on the distances that the several patients included in the test were able to achieve during a six-minute walk at submaximal effort levels, a definite correlation was found, with the distance walked being inversely related to patient mortality and morbidity. See
FIGS. 1 and 2
. A similar study with similar outcomes is described in a paper entitled “Using a Six-Minute Walk Test to Predict Outcomes in Patients with Left Ventricular Dysfunction” by Nancy P. Milligan, R.N. et al., published in the July/August 1997 edition of
Rehabilitation Nursing
(Vol. 22, No. 4, pp. 177-181).
The six-minute walk test is generally carried out under closely controlled conditions in a hospital or clinic. Patients are asked to walk up and down a corridor at their own rate as a medical professional times and calculates the distance traversed in a six-minute period. A pedometer affixed to the patient's leg may be used to determine the distance traversed, but usually the distance is determined from the length of the corridor and the number of times the patient has walked it in a six-minute period.
Activity can also be measured by means of an accelerometer affixed to the patient. As is pointed out in an article by C. V. C. Bouten et al. entitled a “Triaxial Accelerometer and Portable Data Processing Unit for the Assessment of Daily Physical Activity”, published in the
IEEE Transactions on Biomedical Engineering
, Vol. 44, No. 3, March 1997, pp. 136-147, information derived from a patient-worn accelerometer can reliably be used for the assessment of that patient's physical activity and it offers the advantage that the information may be gathered in the course of more normal patient activities. Studies we have conducted show a direct, positive correlation between the frequency with which the output from a patient-worn accelerometer exceeds a predetermined threshold and the distance traversed during a six-minute walk test protocol. Therefore, we are able to conclude that accelerometer-derived data can be used in assessing patient well-being and we have developed an apparatus and algorithm using an activity sensor to assess the efficacy of a change in pacing therapy on that patient's overall well-being.
SUMMARY OF THE INVENTION
As mentioned, the present invention provides apparatus and a method of using same for determining whether a change in a mode of pacing a CHF patient enhances or decreases that patient's overall well-being. It can also be used to assess efficacy of different rate responsive algorithms for rate responsive pacemakers. The method involves the steps of affixing to the patient one or more sensors capable of sensing a parameter related to the patient's level of activity and for providing an electrical output signal(s) corresponding to such activity level. A monitoring protocol is established which defines (1) a total time period in which the assessment is to be accomplished, (2) a plurality of first time periods in which different pacing modes are employed in each, and (3) the number of instances within each of the plurality of time periods that the sensor output signals are sampled over a given time interval that is short compared to the first time periods. In each of the given time intervals, the frequency with which the electrical output from the sensor exceeds a predetermined threshold is determined and that frequency value is stored in a memory for subsequent read-out. The steps of determining the frequency that the sensor output(s) exceeds the predetermined threshold and the storing of the frequency values is repeated for the number of instances defined in the protocol and when all of the instances have been accommodated, an average of all of the frequency values is calculated and stored as an activity log. By performing the foregoing steps for each of the modes established in the protocol, the physician, upon read-out of the stored activity log data, is able to assess the efficacy of the pacing mode changes on patient well-being.
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Vera Bittner, M.D. et al., “Prediction of Mortality and Morbidity With a 6-Minute Walk Test in Patients With Left Ventricular Dysfunction”,Journal of the American Medical Association, Oct. 13, 1993, vol. 270, No. 14, pp. 1702-1707.
Nancy P. Milligan, et al. “Using a 6-Minute Walk Test to Predict Outcomes in Patients with Left Ventricular Dysfunction”,Rehabilitation Nursing, Jul./Aug. 1997, vol. 22, No. 4, pp. 177-181.
Carlijn V.C. Bouten, et al. “A Triaxial Accelerometer and Portable Data Processing Unit for the Assessment of Daily Physical Activity”,IEEE Transactions On Biomedical Engineering, Mar. 1997, vol. 44, No., pp. 136-147.
Nicolas Delahayne, M.D., et al. “Comparison of Left Ventricular Responses to the Six-Minute Walk Test, Stair Climbing, and Maximal Upright Bicycle Exercise in Patients With Congestive Heart Failure Due to Idiopathic Dilated Cardiomyopathy”,The American Journal of Cardiology, Jul. 1, 1997, vol. 80, pp. 70.
John T. Walsh, et al. “Relation of Daily Activity Levels in Patients with Chronic Heart Failure to Long-Term Prognosis”,The American Journal of Cardiology, May 15, 1997, vol. 79, pp. 1364-1369.
Kadhiresan Veerichetty A.
Spinelli Julio C.
Bockelman Mark
Cardiac Pacemakers Inc.
Nikolai Thomas J.
Nikolai & Mersereau , P.A.
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