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Smart Phone Enabled ECG Recording Can Scale for the U.S. Heart Failure Ambulatory Population
S34 Journal of Cardiac Failure Vol. 20 No. 8S August 2014 Table.
083 Decreased Creatinine Production in Heart Failure Patients Undergoing LVAD Placement Leads to Overestimates of Renal Function Meredith A. Brisco1, Anthony Hale1, Dawn P. Heyward1, Jennifer L. Peura1, Walt E. Uber1, Michael R. Zile1, John Arthur1, Jeffrey M. Testani2; 1Medical University of South Carolina, Charleston, SC; 2Yale University School of Medicine, New Haven, CT Background: Renal dysfunction (RD) is common in heart failure (HF) and is an important predictor of mortality in patients undergoing left ventricular assist device (LVAD) placement. Evaluation of renal function in LVAD candidates is generally accomplished via serum creatinine (Cr) based estimates. This is problematic since Cr level is influenced not only by renal function but also the amount of Cr produced by skeletal muscle. Since cardiac cachexia is common in HF, it is unclear to what degree reduced muscle mass and Cr production will affect estimates of glomerular filtration rate (GFR). Hypothesis: We hypothesized that, in patients referred for LVAD placement, Cr production would be significantly lower than predicted resulting in a significant underestimation of the burden of RD in these patients. Methods: Consecutive adult patients who underwent LVAD placement with 24-hour Cr collections available were studied (n562). Cr production was determined using the 24 hour cumulative Cr excretion; measured Cr clearance was calculated using the standard clearance equation. Renal function was also estimated from the serum Cr using the Cockgroft-Gault (CG) equation and the CKD-EPI equation. All parameters of renal function were indexed to a BSA of 1.73 m2. Results: The mean age of the cohort was 54.5 6 14.6 years, 74.3% (n546) were male and 51.6% (n532) were African American. Despite an elevated BMI of 29.9 6 8.06 kg/m2, the mean 24 hour Cr excretion was only 1279 6 474 mg (compared to a predicted value in this cohort of 1938 6 615 mg, p!0.001) confirming marked sarcopenia. Overall, less than 30% of patients’ Cr excretion was in the normal range after accounting for age and BSA. Significant preLVAD RD was present with a mean measured Cr clearance of 49.5 6 22.3 ml/min/ 1.732. Both the CG and the CKD-EPI equation overestimated GFR with a median error of 22.3% (10.9-34.0%) and 19.8 % (10.4-31.2%) respectively. This translated into 25.8% of the patients being misclassified using CKD-EPI and 35.5% being misclassified by CG into a greater CKD stage than indicated by measured Cr clearance. Conclusions: HF patients undergoing LVAD placement exhibit decreased Cr production likely as a result of significant cardiac cachexia. Since GFR estimation equations assume normal Cr production, this led to significant overestimation of GFR and misclassification of patients into higher CKD stages. Further research is necessary to determine if non-creatinine based metrics of renal function could improve preLVAD evaluation of RD.
084 Outpatient Management of Gastrointestinal Bleeding in Patients with Continuous-Flow Left Ventricular Assist Devices David S. Raymer1, Michael E. Nassif1, Surachai Amornsawadwattana1, Heidi Craddock1, Molly Rater1, Shane J. LaRue1, Scott C. Silvestry2, Gregory A. Ewald1; 1Washington University/Barnes-Jewish Hospital, St. Louis, MO; 2Washington University/Barnes-Jewish Hospital, St. Louis, MO Introduction: Gastrointestinal bleeding (GIB) is a common complication following continuous-flow left ventricular assist devices (CF-LVADs) implantation, for which the optimal evaluation and management strategy is unclear. Outpatient transfusion and serial follow up without hospitalization or endoscopy may be a safe and costeffective management strategy in select patients. Methods: We identified six patients (all men, mean age 72, range 63-82) with implanted CF-LVADs (5 Heart Mate II, 1 HVAD) complicated by recurrent GIB managed with outpatient transfusions. All patients had undergone prior endoscopic evaluation during a previous GIB event. The patients were followed from 9/2010 to 9/2013. Baseline medications were analyzed to evaluate the risk of bleeding with their use. Multiple outcomes were assessed including blood transfusions, number of procedures, rate of treatment failure (defined as requiring hospitalization within 5 days of outpatient transfusion), hospital length of stay, and death. Mean follow-up time was 23.9 months. Results: There were 58 total GIB events: 28 were inpatient events and 30 were outpatient events. Outpatient events had higher mean hemoglobin (7.47 g/dL vs. 6.98 g/dL, p 5 0.022), and higher mean creatinine (1.72 mg/dL vs. 1.28 mg/dL, p 5 0.013). There were no significant differences with respect to aspirin use, aspirin dose, PPI use, INR, platelet counts, or LDH. There were no procedures performed for outpatient events in contrast to 46 for inpatient events: 15 esophagogastroduodenoscopies, 12 colonoscopies, 16 smallbowel enteroscopies, and 3 capsule endoscopies. Packed red blood cell transfusions totaled 141 units for inpatient and 64 units for outpatient events, with a mean units per event of 5.0 and 2.1, respectively (p ! 0.0001, see table). The mean length of hospitalization for inpatient events was 10 days. Outpatient treatment failure occurred 4 times (13.3%). The only death occurred while a patient was on hospice. Conclusion: In a highly selected cohort of patients with CF-LVADs complicated by recurrent GIB having previously undergone endoscopic evaluation, an outpatient transfusion strategy eliminated procedures, reduced transfusions, and had a low failure rate. This strategy may be reasonable for patients with recurrent bleeding events and should be further tested prospectively.
Patient Outcomes Inpatient Outpatient Events(n528) Events(n530) Total Units of PRBCs Units of PRBCs per Episode Total Procedures EGD Colonoscopy Small Bowel Enteroscopy Capsule Endoscopy
141 5 46 15 12 16 3
64 2.1 0 0 0 0 0
P-value ! 0.0001 ! 0.0001 -
085 Smart Phone Enabled ECG Recording Can Scale for the U.S. Heart Failure Ambulatory Population Rupan Bose1, David E. Albert2, Fei Wang2, Leslie A. Saxon1; 1University of Southern California, Los Angeles, CA; 2AliveCor, San Francisco, CA Introduction: Nearly 5.1 million Americans have Heart Failure, and the disease prevalence is projected to increase 46% from 2012 to 2030. Additionally, 56% of U.S. adults have smartphones, and that number is growing rapidly. Smartphone enabled ECG recording devices, FDA approved for both prescriptive and over-thecounter use, represent a new method for large scale, real-time on-demand cardiac screening, diagnosis, and monitoring. Hypothesis: A smartphone enabled ECG recording device can be deployed easily and can be used to collect heart rate and rhythm data. Since the device can be initiated by the patient, it can allow for continuous and efficient wireless patient monitoring. Algorithms for arrhythmia diagnosis can be applied to the remotely acquired ECG. Methods: Data was analyzed from an unselected group of U.S. patients that recorded real-time thirty-second ECG tracings on their devices and wirelessly transmitted the recordings to a secure server (AliveCor, San Francisco, CA). The study patient population included patients enrolled in clinical trials of the device (15% of patient population) and those that were prescribed the device for self-monitoring. Results: A total of 564,117 transmissions were received over an average device-use duration of 158 days. A total of 8,669 patients (mean age of 56 6 18 years, 61% male) transmitted a mean of 65 30-second continuous ECG transmissions each. Mean heart rate over the population was 77.8 6 21.8 bpm (Figure). The atrial rhythm was AF in 20.1% of transmissions. Conclusions: Providing patients with the ability to easily record ECGs has the potential to radically disrupt the way cardiac screening, diagnosis, and monitoring is performed for U.S. heart failure patients. This method can easily be scaled in the U.S. and globally.
Figure.
086 Outcomes with Medical Management of Continuous Flow Left Ventricular Assist Device(CF-LVAD) Thrombosis Rudhir Tandon1, Chakradhari Inampudi2, Jennifer Franzwa1, Jennifer GoerbigCampbell1; 1University of Iowa Hospitals and Clinics, Iowa City, IA; 2University of Iowa Hospitals and Clinics, Iowa City, IA Objective: Pump thrombosis is a feared complication among patients who receive a CF-LVAD for medically refractory advanced heart failure. Herein, we describe the incidence of pump thrombosis and compare the outcomes utilizing various treatment strategies including a medical management strategy as advocated in current literature. Methods: We retrospectively reviewed the charts of 78 consecutive patients (81%
083 Decreased Creatinine Production in Heart Failure Patients Undergoing LVAD Placement Leads to Overestimates of Renal Function Meredith A. Brisco1, Anthony Hale1, Dawn P. Heyward1, Jennifer L. Peura1, Walt E. Uber1, Michael R. Zile1, John Arthur1, Jeffrey M. Testani2; 1Medical University of South Carolina, Charleston, SC; 2Yale University School of Medicine, New Haven, CT Background: Renal dysfunction (RD) is common in heart failure (HF) and is an important predictor of mortality in patients undergoing left ventricular assist device (LVAD) placement. Evaluation of renal function in LVAD candidates is generally accomplished via serum creatinine (Cr) based estimates. This is problematic since Cr level is influenced not only by renal function but also the amount of Cr produced by skeletal muscle. Since cardiac cachexia is common in HF, it is unclear to what degree reduced muscle mass and Cr production will affect estimates of glomerular filtration rate (GFR). Hypothesis: We hypothesized that, in patients referred for LVAD placement, Cr production would be significantly lower than predicted resulting in a significant underestimation of the burden of RD in these patients. Methods: Consecutive adult patients who underwent LVAD placement with 24-hour Cr collections available were studied (n562). Cr production was determined using the 24 hour cumulative Cr excretion; measured Cr clearance was calculated using the standard clearance equation. Renal function was also estimated from the serum Cr using the Cockgroft-Gault (CG) equation and the CKD-EPI equation. All parameters of renal function were indexed to a BSA of 1.73 m2. Results: The mean age of the cohort was 54.5 6 14.6 years, 74.3% (n546) were male and 51.6% (n532) were African American. Despite an elevated BMI of 29.9 6 8.06 kg/m2, the mean 24 hour Cr excretion was only 1279 6 474 mg (compared to a predicted value in this cohort of 1938 6 615 mg, p!0.001) confirming marked sarcopenia. Overall, less than 30% of patients’ Cr excretion was in the normal range after accounting for age and BSA. Significant preLVAD RD was present with a mean measured Cr clearance of 49.5 6 22.3 ml/min/ 1.732. Both the CG and the CKD-EPI equation overestimated GFR with a median error of 22.3% (10.9-34.0%) and 19.8 % (10.4-31.2%) respectively. This translated into 25.8% of the patients being misclassified using CKD-EPI and 35.5% being misclassified by CG into a greater CKD stage than indicated by measured Cr clearance. Conclusions: HF patients undergoing LVAD placement exhibit decreased Cr production likely as a result of significant cardiac cachexia. Since GFR estimation equations assume normal Cr production, this led to significant overestimation of GFR and misclassification of patients into higher CKD stages. Further research is necessary to determine if non-creatinine based metrics of renal function could improve preLVAD evaluation of RD.
084 Outpatient Management of Gastrointestinal Bleeding in Patients with Continuous-Flow Left Ventricular Assist Devices David S. Raymer1, Michael E. Nassif1, Surachai Amornsawadwattana1, Heidi Craddock1, Molly Rater1, Shane J. LaRue1, Scott C. Silvestry2, Gregory A. Ewald1; 1Washington University/Barnes-Jewish Hospital, St. Louis, MO; 2Washington University/Barnes-Jewish Hospital, St. Louis, MO Introduction: Gastrointestinal bleeding (GIB) is a common complication following continuous-flow left ventricular assist devices (CF-LVADs) implantation, for which the optimal evaluation and management strategy is unclear. Outpatient transfusion and serial follow up without hospitalization or endoscopy may be a safe and costeffective management strategy in select patients. Methods: We identified six patients (all men, mean age 72, range 63-82) with implanted CF-LVADs (5 Heart Mate II, 1 HVAD) complicated by recurrent GIB managed with outpatient transfusions. All patients had undergone prior endoscopic evaluation during a previous GIB event. The patients were followed from 9/2010 to 9/2013. Baseline medications were analyzed to evaluate the risk of bleeding with their use. Multiple outcomes were assessed including blood transfusions, number of procedures, rate of treatment failure (defined as requiring hospitalization within 5 days of outpatient transfusion), hospital length of stay, and death. Mean follow-up time was 23.9 months. Results: There were 58 total GIB events: 28 were inpatient events and 30 were outpatient events. Outpatient events had higher mean hemoglobin (7.47 g/dL vs. 6.98 g/dL, p 5 0.022), and higher mean creatinine (1.72 mg/dL vs. 1.28 mg/dL, p 5 0.013). There were no significant differences with respect to aspirin use, aspirin dose, PPI use, INR, platelet counts, or LDH. There were no procedures performed for outpatient events in contrast to 46 for inpatient events: 15 esophagogastroduodenoscopies, 12 colonoscopies, 16 smallbowel enteroscopies, and 3 capsule endoscopies. Packed red blood cell transfusions totaled 141 units for inpatient and 64 units for outpatient events, with a mean units per event of 5.0 and 2.1, respectively (p ! 0.0001, see table). The mean length of hospitalization for inpatient events was 10 days. Outpatient treatment failure occurred 4 times (13.3%). The only death occurred while a patient was on hospice. Conclusion: In a highly selected cohort of patients with CF-LVADs complicated by recurrent GIB having previously undergone endoscopic evaluation, an outpatient transfusion strategy eliminated procedures, reduced transfusions, and had a low failure rate. This strategy may be reasonable for patients with recurrent bleeding events and should be further tested prospectively.
Patient Outcomes Inpatient Outpatient Events(n528) Events(n530) Total Units of PRBCs Units of PRBCs per Episode Total Procedures EGD Colonoscopy Small Bowel Enteroscopy Capsule Endoscopy
141 5 46 15 12 16 3
64 2.1 0 0 0 0 0
P-value ! 0.0001 ! 0.0001 -
085 Smart Phone Enabled ECG Recording Can Scale for the U.S. Heart Failure Ambulatory Population Rupan Bose1, David E. Albert2, Fei Wang2, Leslie A. Saxon1; 1University of Southern California, Los Angeles, CA; 2AliveCor, San Francisco, CA Introduction: Nearly 5.1 million Americans have Heart Failure, and the disease prevalence is projected to increase 46% from 2012 to 2030. Additionally, 56% of U.S. adults have smartphones, and that number is growing rapidly. Smartphone enabled ECG recording devices, FDA approved for both prescriptive and over-thecounter use, represent a new method for large scale, real-time on-demand cardiac screening, diagnosis, and monitoring. Hypothesis: A smartphone enabled ECG recording device can be deployed easily and can be used to collect heart rate and rhythm data. Since the device can be initiated by the patient, it can allow for continuous and efficient wireless patient monitoring. Algorithms for arrhythmia diagnosis can be applied to the remotely acquired ECG. Methods: Data was analyzed from an unselected group of U.S. patients that recorded real-time thirty-second ECG tracings on their devices and wirelessly transmitted the recordings to a secure server (AliveCor, San Francisco, CA). The study patient population included patients enrolled in clinical trials of the device (15% of patient population) and those that were prescribed the device for self-monitoring. Results: A total of 564,117 transmissions were received over an average device-use duration of 158 days. A total of 8,669 patients (mean age of 56 6 18 years, 61% male) transmitted a mean of 65 30-second continuous ECG transmissions each. Mean heart rate over the population was 77.8 6 21.8 bpm (Figure). The atrial rhythm was AF in 20.1% of transmissions. Conclusions: Providing patients with the ability to easily record ECGs has the potential to radically disrupt the way cardiac screening, diagnosis, and monitoring is performed for U.S. heart failure patients. This method can easily be scaled in the U.S. and globally.
Figure.
086 Outcomes with Medical Management of Continuous Flow Left Ventricular Assist Device(CF-LVAD) Thrombosis Rudhir Tandon1, Chakradhari Inampudi2, Jennifer Franzwa1, Jennifer GoerbigCampbell1; 1University of Iowa Hospitals and Clinics, Iowa City, IA; 2University of Iowa Hospitals and Clinics, Iowa City, IA Objective: Pump thrombosis is a feared complication among patients who receive a CF-LVAD for medically refractory advanced heart failure. Herein, we describe the incidence of pump thrombosis and compare the outcomes utilizing various treatment strategies including a medical management strategy as advocated in current literature. Methods: We retrospectively reviewed the charts of 78 consecutive patients (81%