Evaluation Of Reduced 30-Day Readmission Rates And Pharmacotherapy Management In Patients Attending Rapid Follow Up Appointments After Hospitalization For Acute Decompensated Heart Failure
HFSA ePoster Library. Rollins B. 09/10/21; 343450; 218
Brett Rollins
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Abstract
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Introduction: Synchronized diaphragmatic stimulation (SDS), a device-based heart failure therapy using a dedicated implantable system which delivers stimulation pulses to the diaphragm gaited with sensed cardiac activity, has been evaluated in a first-in-human study (NCT03484780). To allow monitoring and trending of patient status, the implanted device records accelerometer-based activity every 15 minutes to provide hourly averages for up to 90 days.
Hypothesis: Device-based activity measurements correlate with other objective measurements of exercise tolerance, HF status and cardiac function.
Methods: HF patients underwent laparoscopic implantation of the VisONE system comprised of a pulse generator and two bipolar sutureless, active fixation leads affixed to the inferior left and right hemispheres of the diaphragm. During the implant procedure, optimal locations and parameters for sensing the QRS complex and delivering SDS pulses are determined. The patients were evaluated at 3, 6 and 12 months post-discharge using standard chronic measures of HF status (LV ejection fraction (LVEF), LV end-systolic volume (LVESV), Short Form (36) Health Survey (SF-36), 6-minute walk test (6MWT)) and the device-based activity measurement.
Results: Twenty patients were screened and fifteen men were enrolled (100% ischemic etiology, 61 ± 7.3 y, LVEF 27.8 ± 5.6%, QRSd 114 ± 14.7 ms, NT-proBNP 1579 ± 756 pg/ml) and successfully implanted. For all patients, a SDS stimulation level could be identified that caused imperceptible localized diaphragmatic contraction. Comparing discharge with SDS off to follow-up with SDS on, statistically and clinically significant improvements (mean of differences, discharge vs 12 months) were seen in 6MWT (37.1 m, p=0.004, see figure), SF-36 role limitations (physical) score (19.2 au, p=0.006), LVEF (4.5 %, p=0.17), LVESV (with SDS off, -33.4 ml/m2, p=0.04) and activity (59.0 au, p=0.006).
Conclusions: Device-based activity measurements with the VisOne system for Synchronized Diaphragmatic Stimulation are a reliable indicator of patient status and a useful tool for non-invasive patient monitoring.
Hypothesis: Device-based activity measurements correlate with other objective measurements of exercise tolerance, HF status and cardiac function.
Methods: HF patients underwent laparoscopic implantation of the VisONE system comprised of a pulse generator and two bipolar sutureless, active fixation leads affixed to the inferior left and right hemispheres of the diaphragm. During the implant procedure, optimal locations and parameters for sensing the QRS complex and delivering SDS pulses are determined. The patients were evaluated at 3, 6 and 12 months post-discharge using standard chronic measures of HF status (LV ejection fraction (LVEF), LV end-systolic volume (LVESV), Short Form (36) Health Survey (SF-36), 6-minute walk test (6MWT)) and the device-based activity measurement.
Results: Twenty patients were screened and fifteen men were enrolled (100% ischemic etiology, 61 ± 7.3 y, LVEF 27.8 ± 5.6%, QRSd 114 ± 14.7 ms, NT-proBNP 1579 ± 756 pg/ml) and successfully implanted. For all patients, a SDS stimulation level could be identified that caused imperceptible localized diaphragmatic contraction. Comparing discharge with SDS off to follow-up with SDS on, statistically and clinically significant improvements (mean of differences, discharge vs 12 months) were seen in 6MWT (37.1 m, p=0.004, see figure), SF-36 role limitations (physical) score (19.2 au, p=0.006), LVEF (4.5 %, p=0.17), LVESV (with SDS off, -33.4 ml/m2, p=0.04) and activity (59.0 au, p=0.006).
Conclusions: Device-based activity measurements with the VisOne system for Synchronized Diaphragmatic Stimulation are a reliable indicator of patient status and a useful tool for non-invasive patient monitoring.
Introduction: Synchronized diaphragmatic stimulation (SDS), a device-based heart failure therapy using a dedicated implantable system which delivers stimulation pulses to the diaphragm gaited with sensed cardiac activity, has been evaluated in a first-in-human study (NCT03484780). To allow monitoring and trending of patient status, the implanted device records accelerometer-based activity every 15 minutes to provide hourly averages for up to 90 days.
Hypothesis: Device-based activity measurements correlate with other objective measurements of exercise tolerance, HF status and cardiac function.
Methods: HF patients underwent laparoscopic implantation of the VisONE system comprised of a pulse generator and two bipolar sutureless, active fixation leads affixed to the inferior left and right hemispheres of the diaphragm. During the implant procedure, optimal locations and parameters for sensing the QRS complex and delivering SDS pulses are determined. The patients were evaluated at 3, 6 and 12 months post-discharge using standard chronic measures of HF status (LV ejection fraction (LVEF), LV end-systolic volume (LVESV), Short Form (36) Health Survey (SF-36), 6-minute walk test (6MWT)) and the device-based activity measurement.
Results: Twenty patients were screened and fifteen men were enrolled (100% ischemic etiology, 61 ± 7.3 y, LVEF 27.8 ± 5.6%, QRSd 114 ± 14.7 ms, NT-proBNP 1579 ± 756 pg/ml) and successfully implanted. For all patients, a SDS stimulation level could be identified that caused imperceptible localized diaphragmatic contraction. Comparing discharge with SDS off to follow-up with SDS on, statistically and clinically significant improvements (mean of differences, discharge vs 12 months) were seen in 6MWT (37.1 m, p=0.004, see figure), SF-36 role limitations (physical) score (19.2 au, p=0.006), LVEF (4.5 %, p=0.17), LVESV (with SDS off, -33.4 ml/m2, p=0.04) and activity (59.0 au, p=0.006).
Conclusions: Device-based activity measurements with the VisOne system for Synchronized Diaphragmatic Stimulation are a reliable indicator of patient status and a useful tool for non-invasive patient monitoring.
Hypothesis: Device-based activity measurements correlate with other objective measurements of exercise tolerance, HF status and cardiac function.
Methods: HF patients underwent laparoscopic implantation of the VisONE system comprised of a pulse generator and two bipolar sutureless, active fixation leads affixed to the inferior left and right hemispheres of the diaphragm. During the implant procedure, optimal locations and parameters for sensing the QRS complex and delivering SDS pulses are determined. The patients were evaluated at 3, 6 and 12 months post-discharge using standard chronic measures of HF status (LV ejection fraction (LVEF), LV end-systolic volume (LVESV), Short Form (36) Health Survey (SF-36), 6-minute walk test (6MWT)) and the device-based activity measurement.
Results: Twenty patients were screened and fifteen men were enrolled (100% ischemic etiology, 61 ± 7.3 y, LVEF 27.8 ± 5.6%, QRSd 114 ± 14.7 ms, NT-proBNP 1579 ± 756 pg/ml) and successfully implanted. For all patients, a SDS stimulation level could be identified that caused imperceptible localized diaphragmatic contraction. Comparing discharge with SDS off to follow-up with SDS on, statistically and clinically significant improvements (mean of differences, discharge vs 12 months) were seen in 6MWT (37.1 m, p=0.004, see figure), SF-36 role limitations (physical) score (19.2 au, p=0.006), LVEF (4.5 %, p=0.17), LVESV (with SDS off, -33.4 ml/m2, p=0.04) and activity (59.0 au, p=0.006).
Conclusions: Device-based activity measurements with the VisOne system for Synchronized Diaphragmatic Stimulation are a reliable indicator of patient status and a useful tool for non-invasive patient monitoring.
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