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Impact of Patient Comorbidities on Post-Implant Outcomes Among Patients Receiving Ventricular Assist Devices in a Commercially Insured Population
S32 Journal of Cardiac Failure Vol. 21 No. 8S August 2015
Surgery/Transplantation/Devices I 050 Impact of Patient Comorbidities on Post-Implant Outcomes Among Patients Receiving Ventricular Assist Devices in a Commercially Insured Population Jiang Tao, Wade Bannister, Charlotte Wu, Frank D. Irwin; Optum, Eden Prairie, MN Introduction: Use of Ventricular Assist Devices (VADs) in patients with advanced heart failure is becoming more prevalent, but post-implant patient outcomes are not yet well understood. In particular, it is not known how pre-existing patient comorbidities may influence outcomes such as survival, length of stay, complication rates, and readmission rates in patients receiving these devices. Objective: To measure association of pre-implant patient comorbidities with VAD-related outcomes including survival, length of stay (LOS), complications, and readmissions in patients receiving mechanical circulatory support devices such as VADs. Methods: VAD implantation patients were drawn from claims data from a large US commercial insurer. Using diagnosis, procedure, and revenue codes in the 90 day period before the implant we identified comorbid conditions: diabetes, hypertension, atrial fibrillation, COPD, history of ischemic heart disease, diagnosed coagulopathy, neurological or neuromuscular disorder, and dialysis. We then utilized up to four years of post-implant claims data to identify outcomes: patient mortality, all-cause inpatient readmission, implant LOS (measured from date of implant to date of discharge), and post-discharge complications including device malfunction, major bleeding, major infection, stroke, hypertension, and renal dysfunction. Kaplan-Meier (K-M) methods and log-rank tests were used to compare time to mortality, inpatient readmission, and complications while t-tests were used to compare implant lengths of stay between patients with and without each comorbidity. Results: We observed 626 VAD cases between 2009 and 2013 with an observation period ending in March 2014. Patients with diabetes compared with those without had higher readmission rates (p50.051), higher complication rates (p50.0076), and longer LOS (34.3 vs 28.9 days, p50.0076). Patients with hypertension had higher complication rates (p!.0001). Atrial fibrillation is associated with higher survival rate (p50.004), higher readmission rate (p50.0007), and longer LOS (32.1 vs 28.7, p50.093). COPD was associated with shorter LOS (27.6 vs 32.1, p50.0506). Diagnosed coagulopathy was not significantly associated with measured outcomes. Patient survival differed for patients with and without ischemic heart disease (p50.0955), while the K-M survival curves cross over at the time of 2 year post implant. Both neurological or neuromuscular disorder and dialysis were associated with higher complication rates (p50.0704 and p50.0104 respectively). Patients with neurological or neuromuscular disorders also had longer LOS compared with those without (48.3 vs 30.1, p50.0011). Conclusions: Among the comorbid conditions included in this study, diabetes, hypertension, atrial fibrillation, COPD, neurological or neuromuscular disorder, and dialysis are significantly associated with post-implant outcomes. The analysis suggests that pre-existing conditions of patients influence the VADrelated outcomes.
METs. The destination therapy LVAD patients who had one or less hospitalizations and finished greater than 10 rehab sessions completed over 1,000 minutes of exercise time with four patients averaging 3.0 METs per session. In contrast, there was one patient who exercised less than 700 minutes at only 2.3 METs who experienced 5 hospitalizations within the next year. Conclusions: There is limited data to support CR as an adjunct in LVAD patients. Although our retrospective study does not show a statistically significant correlation between rehab potential and long term survival and hospitalizations in LVAD patients, we do see a decreasing trend in total hospitalizations in patients who completed greater than 1,000 minutes of exercise at greater than 3.0 METs. We also note lower METs on average and total minutes of exercise in patients with early deaths. This study was limited by its retrospective nature, the small sample size and the fact that a significant portion of patients were transplanted before completing phase II CR.
052 Heart Rate and Respiration During Activity Measured by an Implanted Device Correlate well with those Measured by a CPX Machine Alan J. Bank1, John Chronakos2, Kenneth C. Beck3, Paji Vitoff3, Colleen Delaney3, Julie Thompson3, Yi Zhang3; 1United Heart & Vascular Clinic, St Paul, MN; 2 Danbury Hospital, Danbury, CT; 3Boston Scientific, St Paul, MN Introduction: Heart Failure (HF) is classified in part by severity of symptoms such as fatigue and shortness of breath experienced during exertion. Physiologic variables associated with these symptoms, such as heart rate (HR) and respiratory rate (RR) measured during activity, could be useful to monitor disease progression. In the PRE-SENSE study, physiologic response to activity (PRA) measured from an implanted device were compared to data from external cardiopulmonary exercise testing equipment (CPX) during a graded exercise test. Methods: Patients (n571) with a COGNISTM cardiac resynchronization therapy defibrillator were enrolled. The device was enabled to run the PRA algorithm, which continuously identifies steady-state activities based on accelerometer (XL) and captures HR and RR during these periods. HR and RR were also collected by CPX equipment. Linear leastsquares regressions of end-stage averages of CPX HR and RR vs. XL were obtained in each patient. Linear interpolation was then performed to determine CPX HR and RR at the same XL levels as the device-based PRA. Linear regression was performed between device- and CPX-based PRA to assess level of agreement. Results: Fiftynine patients (62610 y.o., 63% male, LVEF 32612%) attained XL of 60 mG (corresponding to 1.5 miles per hour walk) during exercise test. Average slopes and R-Square from linear regression comparison of CPX vs PRA at fixed XL levels are listed below. Conclusions: Physiologic response to activity can be quantified by implanted devices and correlates well with CPX measurements. These results support the potential use of PRA obtained automatically from implantable devices for heart failure monitoring.
051 Predictors of Outcome Using Phase II Cardiac Rehabilitation Data in Patients With Durable, Implanted Left Ventricular Assist Devices Kathleen Morris, Jonathan Shirazi, Milena Jani, I-Wen Wang, Kathleen A. Lane, Stanley Taylor, Changyu Shen, Adnan Malik; IU School of Medicine, Indianapolis, IN Introduction: Implanted mechanical circulatory support is becoming a more widely established therapy for patients with end stage heart failure. Cardiac rehabilitation (CR) as an adjunct is indicated for patients who are post myocardial infarction, valve replacement, coronary bypass grafting and now left ventricular assist device placement (LVAD). CR is a structured inpatient/outpatient program that utilizes physicians, RNs, and exercise therapists to help patients recover and minimize their risks of enduring any further cardiovascular injury. Specifically, phase II rehab is outpatient therapy where patients undergo closely monitored exercise sessions. Reedy et al completed a prospective study to demonstrate that early mobilization in LVAD patients can improve exercise capability and survival rates. Hypothesis: The aim of this study was to evaluate the correlation between performance during CR sessions to morbidity, mortality, duration of survival and hospitalizations in patients with LVAD. Methods: We conducted a retrospective, cross-sectional study within Indiana University Health System from 2008 to 2013 of patients with either a Heartware or Heartmate II LVAD as destination therapy or bridge to transplant who underwent phase II CR. We reviewed demographics, heart disease etiology, phase II rehab data including exercise hemodynamics, workload (METs) and duration of sessions. In addition, the number of hospitalizations and end outcome was retrieved for comparison. Results: There were eight patients who were transplanted, nine patients who survived with LVADs as destination therapy and three patient deaths. The average number of phase II rehab sessions attended was 23.3 with 39.6 minutes exercised at 2.5 METs. Of the three patients that died, they had two hospitalizations each and exercised for less than 1,000 total minutes at an average of 2.2
Table 1. Linear regression comparison of HR and RR interpolated to fixed XL levels by PRA (Y) vs CPX (X)
Heart Rate Activity Level (XL, mG) 0 10 20 30 40 50 60
Respiratory Rate
R-Square
Slope
R-Square
Slope
0.798 0.839 0.875 0.904 0.924 0.935 0.938
0.842 0.855 0.869 0.882 0.882 0.905 0.913
0.584 0.624 0.660 0.688 0.688 0.724 0.733
0.505 0.529 0.560 0.594 0.594 0.669 0.705
053 The Safety of Right Heart Catheterization in Patients with Continuous-Flow Left Ventricular Assist Devices Kershaw Patel, Daniel Rodgers, Cory Henderson, Emeka Anyanwu, Savitri Fedson, Gene Kim, Nitasha Sarswat, Colleen Juricek, Takeyoshi Ota, Valluvan Jeevanandam, Gabriel Sayer, Nir Uriel; University of Chicago, Chicago, IL
Background: Right heart catheterization (RHC) is a crucial tool in the management of patients with continuous-flow left ventricular assist devices (CF-LVADs). Patients with
Surgery/Transplantation/Devices I 050 Impact of Patient Comorbidities on Post-Implant Outcomes Among Patients Receiving Ventricular Assist Devices in a Commercially Insured Population Jiang Tao, Wade Bannister, Charlotte Wu, Frank D. Irwin; Optum, Eden Prairie, MN Introduction: Use of Ventricular Assist Devices (VADs) in patients with advanced heart failure is becoming more prevalent, but post-implant patient outcomes are not yet well understood. In particular, it is not known how pre-existing patient comorbidities may influence outcomes such as survival, length of stay, complication rates, and readmission rates in patients receiving these devices. Objective: To measure association of pre-implant patient comorbidities with VAD-related outcomes including survival, length of stay (LOS), complications, and readmissions in patients receiving mechanical circulatory support devices such as VADs. Methods: VAD implantation patients were drawn from claims data from a large US commercial insurer. Using diagnosis, procedure, and revenue codes in the 90 day period before the implant we identified comorbid conditions: diabetes, hypertension, atrial fibrillation, COPD, history of ischemic heart disease, diagnosed coagulopathy, neurological or neuromuscular disorder, and dialysis. We then utilized up to four years of post-implant claims data to identify outcomes: patient mortality, all-cause inpatient readmission, implant LOS (measured from date of implant to date of discharge), and post-discharge complications including device malfunction, major bleeding, major infection, stroke, hypertension, and renal dysfunction. Kaplan-Meier (K-M) methods and log-rank tests were used to compare time to mortality, inpatient readmission, and complications while t-tests were used to compare implant lengths of stay between patients with and without each comorbidity. Results: We observed 626 VAD cases between 2009 and 2013 with an observation period ending in March 2014. Patients with diabetes compared with those without had higher readmission rates (p50.051), higher complication rates (p50.0076), and longer LOS (34.3 vs 28.9 days, p50.0076). Patients with hypertension had higher complication rates (p!.0001). Atrial fibrillation is associated with higher survival rate (p50.004), higher readmission rate (p50.0007), and longer LOS (32.1 vs 28.7, p50.093). COPD was associated with shorter LOS (27.6 vs 32.1, p50.0506). Diagnosed coagulopathy was not significantly associated with measured outcomes. Patient survival differed for patients with and without ischemic heart disease (p50.0955), while the K-M survival curves cross over at the time of 2 year post implant. Both neurological or neuromuscular disorder and dialysis were associated with higher complication rates (p50.0704 and p50.0104 respectively). Patients with neurological or neuromuscular disorders also had longer LOS compared with those without (48.3 vs 30.1, p50.0011). Conclusions: Among the comorbid conditions included in this study, diabetes, hypertension, atrial fibrillation, COPD, neurological or neuromuscular disorder, and dialysis are significantly associated with post-implant outcomes. The analysis suggests that pre-existing conditions of patients influence the VADrelated outcomes.
METs. The destination therapy LVAD patients who had one or less hospitalizations and finished greater than 10 rehab sessions completed over 1,000 minutes of exercise time with four patients averaging 3.0 METs per session. In contrast, there was one patient who exercised less than 700 minutes at only 2.3 METs who experienced 5 hospitalizations within the next year. Conclusions: There is limited data to support CR as an adjunct in LVAD patients. Although our retrospective study does not show a statistically significant correlation between rehab potential and long term survival and hospitalizations in LVAD patients, we do see a decreasing trend in total hospitalizations in patients who completed greater than 1,000 minutes of exercise at greater than 3.0 METs. We also note lower METs on average and total minutes of exercise in patients with early deaths. This study was limited by its retrospective nature, the small sample size and the fact that a significant portion of patients were transplanted before completing phase II CR.
052 Heart Rate and Respiration During Activity Measured by an Implanted Device Correlate well with those Measured by a CPX Machine Alan J. Bank1, John Chronakos2, Kenneth C. Beck3, Paji Vitoff3, Colleen Delaney3, Julie Thompson3, Yi Zhang3; 1United Heart & Vascular Clinic, St Paul, MN; 2 Danbury Hospital, Danbury, CT; 3Boston Scientific, St Paul, MN Introduction: Heart Failure (HF) is classified in part by severity of symptoms such as fatigue and shortness of breath experienced during exertion. Physiologic variables associated with these symptoms, such as heart rate (HR) and respiratory rate (RR) measured during activity, could be useful to monitor disease progression. In the PRE-SENSE study, physiologic response to activity (PRA) measured from an implanted device were compared to data from external cardiopulmonary exercise testing equipment (CPX) during a graded exercise test. Methods: Patients (n571) with a COGNISTM cardiac resynchronization therapy defibrillator were enrolled. The device was enabled to run the PRA algorithm, which continuously identifies steady-state activities based on accelerometer (XL) and captures HR and RR during these periods. HR and RR were also collected by CPX equipment. Linear leastsquares regressions of end-stage averages of CPX HR and RR vs. XL were obtained in each patient. Linear interpolation was then performed to determine CPX HR and RR at the same XL levels as the device-based PRA. Linear regression was performed between device- and CPX-based PRA to assess level of agreement. Results: Fiftynine patients (62610 y.o., 63% male, LVEF 32612%) attained XL of 60 mG (corresponding to 1.5 miles per hour walk) during exercise test. Average slopes and R-Square from linear regression comparison of CPX vs PRA at fixed XL levels are listed below. Conclusions: Physiologic response to activity can be quantified by implanted devices and correlates well with CPX measurements. These results support the potential use of PRA obtained automatically from implantable devices for heart failure monitoring.
051 Predictors of Outcome Using Phase II Cardiac Rehabilitation Data in Patients With Durable, Implanted Left Ventricular Assist Devices Kathleen Morris, Jonathan Shirazi, Milena Jani, I-Wen Wang, Kathleen A. Lane, Stanley Taylor, Changyu Shen, Adnan Malik; IU School of Medicine, Indianapolis, IN Introduction: Implanted mechanical circulatory support is becoming a more widely established therapy for patients with end stage heart failure. Cardiac rehabilitation (CR) as an adjunct is indicated for patients who are post myocardial infarction, valve replacement, coronary bypass grafting and now left ventricular assist device placement (LVAD). CR is a structured inpatient/outpatient program that utilizes physicians, RNs, and exercise therapists to help patients recover and minimize their risks of enduring any further cardiovascular injury. Specifically, phase II rehab is outpatient therapy where patients undergo closely monitored exercise sessions. Reedy et al completed a prospective study to demonstrate that early mobilization in LVAD patients can improve exercise capability and survival rates. Hypothesis: The aim of this study was to evaluate the correlation between performance during CR sessions to morbidity, mortality, duration of survival and hospitalizations in patients with LVAD. Methods: We conducted a retrospective, cross-sectional study within Indiana University Health System from 2008 to 2013 of patients with either a Heartware or Heartmate II LVAD as destination therapy or bridge to transplant who underwent phase II CR. We reviewed demographics, heart disease etiology, phase II rehab data including exercise hemodynamics, workload (METs) and duration of sessions. In addition, the number of hospitalizations and end outcome was retrieved for comparison. Results: There were eight patients who were transplanted, nine patients who survived with LVADs as destination therapy and three patient deaths. The average number of phase II rehab sessions attended was 23.3 with 39.6 minutes exercised at 2.5 METs. Of the three patients that died, they had two hospitalizations each and exercised for less than 1,000 total minutes at an average of 2.2
Table 1. Linear regression comparison of HR and RR interpolated to fixed XL levels by PRA (Y) vs CPX (X)
Heart Rate Activity Level (XL, mG) 0 10 20 30 40 50 60
Respiratory Rate
R-Square
Slope
R-Square
Slope
0.798 0.839 0.875 0.904 0.924 0.935 0.938
0.842 0.855 0.869 0.882 0.882 0.905 0.913
0.584 0.624 0.660 0.688 0.688 0.724 0.733
0.505 0.529 0.560 0.594 0.594 0.669 0.705
053 The Safety of Right Heart Catheterization in Patients with Continuous-Flow Left Ventricular Assist Devices Kershaw Patel, Daniel Rodgers, Cory Henderson, Emeka Anyanwu, Savitri Fedson, Gene Kim, Nitasha Sarswat, Colleen Juricek, Takeyoshi Ota, Valluvan Jeevanandam, Gabriel Sayer, Nir Uriel; University of Chicago, Chicago, IL
Background: Right heart catheterization (RHC) is a crucial tool in the management of patients with continuous-flow left ventricular assist devices (CF-LVADs). Patients with