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SIPAT Scores Do Not Correlate with Outcomes in Patients with Ventricular Assist Devices
Abstracts
S447
Purpose: Severe left ventricular (LV) dysfunction often presents with left ventricular thrombi (LVT). Data on patients with LVT who receive a left ventricular assist device (LVAD) are scarce. We aimed to analyze the comparative diagnostic value of a pre-implant transthoracic echocardiogram (TTE) for LVT detection against the intraoperative findings at LVAD implantation. Methods: We reviewed patient characteristics, TTE images, transesophageal echocardiographic images, intraoperative findings and pathology reports from the Center for Advanced Heart Failure Data Registry from May 2012 to August 2018. 299 patients received their first LVAD in this period, 238 of them had an LVAD implanted with the use of cardiopulmonary bypass (CPB), and 61 underwent operations without the use of CPB. In all patients who had CPB during their operation, the left ventricle was intraoperatively visually explored. We analyzed the results of 233 patients who had complete data sets. Results: Preoperative TTE identified LVT in 23 of the 233 patients (9.9%); 15 patients (6.4 %) had LVT confirmed via intraventricular visualization. Most of the LVTs were located in the LV apex. Of the 15 patients with visual LVT confirmation, the preoperative TTEs identified an LVT on all but one case. Thus, preoperative TTEs of LVT had a high sensitivity (93%) and specificity (96%), as well as high positive (61%) and negative predictive values (99.5%). In patients with preoperatively identified LVT, all thrombi were removed during LVAD implantation. As compared to those without, patients with LVT were younger (44 § 17 vs. 56 § 13 y, p=0.007) and had a lower prevalence of arterial hypertension (50% vs 92%, p<0.001), hyperlipidemia (38% vs. 74%, p=0.003) and implantable cardioverter-defibrillator (38% vs 74%, p=0.001). Conclusion: This is the largest and most complete study to assess TTE accuracy compared with intraoperative findings in LVAD patients. TTE is a reliable method for the assessment of LVT before LVAD implantation.
1129 Deep Y-Descent in Right Atrial Waveforms is Associated with RV Dysfunction and Worse Outcome in LVAD Patients T. Imamura, A. Nguyen, D. Nitta, S. Kalantari, B. Smith, J. Raikhelkar, N. Narang, B. Chung, I. Ebong, L. Holzhauser, T. Fujino, C. Juricek, P. Combs, D. Onsager, T. Song, T. Ota, V. Jeevanandam, G. Kim, G. Sayer and N. Uriel. University of Chicago, Chicago, IL. Purpose: Right atrial waveform provides diagnostic and clinical information in heart failure patients. Notably, the y-descent (Figure 1A) may provide information about right ventricular systolic and diastolic function. We aimed to investigate the clinical implication of right atrial waveform in LVAD patients. Methods: Patients underwent right heart catheterization (RHC) at 6 months following LVAD implantation and were followed for 1 year afterwards. Impact of a deep y-descent (>3 mmHg) on echocardiographic RA and RV function and clinical outcomes were investigated. Results: 56 LVAD patients (mean age 56.2 years, 77% male) underwent RHC. Patients with post-LVAD deep y-descent (N = 22 [39%]) had increased right ventricular size and worse right ventricular function (Table 1A). The patients with deep y-descent had higher rates of GI bleeding (1.10 vs. 0.32 event/year), stroke (0.28 vs. 0.0 event/year), and heart failure readmissions (0.57 vs. 0.12 events/year) compared to those without (p <0.05 for all; Figure 1B). Conclusion: Deep y-descent of the right atrial waveform during LVAD support is associated with impaired right ventricular function and worse clinical outcomes.
1130 SIPAT Scores Do Not Correlate with Outcomes in Patients with Ventricular Assist Devices K.L. Morris,1 S. Wagner,1 Y. Reddy,2 C. Salerno,1 A. Ravichandran,1 R. Garcia-Cortes,1 A. Patel,1 S. Plotner,1 J. Hart,1 K. Neawedde,1 M.N. Walsh,1 and S.P. Chaudhry.1 1St. Vincent Heart Center of Indiana, Indianapolis, IN; and the 2The Mayo Clinic, Rochester, MN. Purpose: The psychosocial evaluation is of paramount importance when evaluating a patient’s ability to be successful with left ventricular assist device (LVAD) therapy. Current guidelines recommend a “detailed psychosocial evaluation” but do not give any recommendations regarding the use of a specific clinical tool. The Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) has been shown to predict both the psychosocial and medical outcomes in patients post-transplant; however, studies examining its utility in LVAD patients are limited. Methods: We performed a single center, retrospective analysis, of 82 consecutive patients who underwent LVAD implantation from May 2017 to September 2018. Patients were classified into two groups based on a validated SIPAT cutoff score of < 21 as “good” or ≥ 21 as a “minimally acceptable” candidate. A time-to-event analysis was performed to examine a composite outcome of death or re-admission for heart failure (HF), bleeding, infection, or stroke. Each component of the composite outcome was also assessed individually.
S448
The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
Results: Of the 82 patients, 46 (56%) had a score < 21, while 36 (44%) had a score ≥ 21. There were no differences in baseline characteristics including age (58 vs 56, p=0.5), gender (Male: 85% vs 72%, p=0.2), INTERMACS class (3 vs 3, p=0.9), EF (18% vs 17%, p=0.4), GFR (71 vs 66, p=0.4), median days on LVAD support (138 vs 164, p=0.9), or device type. There was no difference in the composite outcome of death or readmission for HF, bleeding, infection, or stroke [Figure 1], or any of the individual components between those with SIPAT scores < 21 versus ≥ 21. Conclusion: Unlike cardiac transplant, the SIPAT score was not predictive of medical outcomes in patients undergoing LVAD therapy. A patient’s underlying biologic effects may influence outcomes more than their psychosocial aspects. Prospective studies should be considered to further explore the validity of the SIPAT score in patients undergoing LVAD implantation.
within the first year was 2.5 § 2.6, and mean number of days to first readmission was 80 § 91. Those with less than a high school education were 55% more likely to experience an adverse event (driveline infection, bacteremia, stroke, hemolysis, GI bleed, other bleed) compared to those with a graduate level education (p < 0.05), but showed no difference in mortality or readmission rates. There was no statistically significant difference in 30day mortality, 1-year mortality, all-cause mortality, days to first readmission, number of readmissions within 1-year, and adverse events based on remaining aforementioned psychosocial risk factors. Conclusion: These results suggest that certain psychosocial factors may not influence mortality or adverse event rates after VAD implantation. Although, education level impacted adverse event rates, further delineation is required. A larger sample size is needed to elucidate exactly which psychosocial characteristics affect VAD outcomes.
1132 Lower Pre-Implantation Psychosocial Risk Scores Do Not Correlate with Better Survival Following Left Ventricular Assist Device (LVAD) Placement N. Grigoryan, L. Brobst, H. Zhao and E. Hamad. Temple University School of Medicine, Philadelphia, PA.
Figure 1
Freedom From Composite Endpoint by SIPAT Score.
1131 Psychosocial Characteristics and Outcomes in Patients with Ventricular Assist Device C. Morreale,1 R. Paliga,2 S. Kothari,1 K. Meehan,2 L. Coyle,2 M. Morack,2 S. Pauwaa,2 G. Macaluso,2 A. Joshi,2 C. Sciamanna,2 A. Tatooles,3 P. Pappas,3 W. Cotts,2 and A. Andrade.2 1Medicine, UIC/ Advocate Christ Medical Center, Oak Lawn, IL; 2Cardiology, Advocate Christ Medical Center, Oak Lawn, IL; and the 3Cardiovascular and Thoracic Surgery, Advocate Christ Medical Center, Oak Lawn, IL. Purpose: Patient selection for durable ventricular assist device (VAD) involves a comprehensive medical and psychosocial evaluation. Although there are guidelines for evaluation of medical comorbidities, psychosocial risk assessment remains somewhat subjective. There is ongoing concern that patients may be denied VAD due to perceived high-risk psychosocial characteristics that may not impact survival after VAD implantation. The purpose of this study was to evaluate the patient psychosocial risk profile and its impact on outcomes after VAD implantation. Methods: This study was a single center, retrospective analysis of 93 patients who underwent durable VAD implantation at Advocate Christ Medical Center in 2016. Psychosocial factors on outcomes were evaluated using the Student’s t-test, Fischer’s exact test, and one-way analysis of variance. Results: Of 93 patients, mean age was 55 § 13 years, 73% were males, 46% were African American, 69% had non-ischemic cardiomyopathy, and 60% received destination therapy. Most prevalent psychosocial factors were: 27% had a pre-existing psychiatric diagnosis, 53% were not married, 22% had no children, 11% lived alone, 19% did not complete a high school education, 26% were chronically unemployed, 55% formerly abused tobacco, 13% formerly abused alcohol, and 24% formerly abused illicit drug. Mean days on device was 589 § 321, mean number of readmissions
Purpose: The assessment of psychosocial risk is an important component in the selection of appropriate candidates for LVAD implementation, however the influence on disease outcome remains poorly studied. In this study, we evaluated the effects of psychosocial risk on mortality, complications, and recurrent admissions. Methods: We performed a retrospective chart review of patients with refractory systolic heart failure who underwent LVAD placement between 2009 and 2018 (N=94). The psychosocial risk, ranging low to high (0-4), was determined through assessment of finances, support system, understanding, compliance, substance abuse, mental health, adjustment, and cognition. The primary outcome was overall survival. Secondary outcomes were development of driveline infections, GI bleeds, other bleeds, stroke, thrombus, and readmissions. Results: The mean age of patients was 57 years, 74% being male. At the end of 2 years, there were 30 deaths (31.9%). At 6, 12, and 24 months, the patients with the lowest psychosocial risk (score 0) had the highest mortality (P=0.043). The number of psychosocial risk factors that each patient had did not affect survival (P=0.21). For secondary outcomes, psychosocial risk did not correlate with development of strokes, thrombi, other bleeds, or readmissions. Patients with higher risk scores developed less GI bleeds than those with lower scores (P=0.018). Conclusion: We found that lower psychosocial risk scores did not correlate with better survival in patients who received an LVAD. However, patients with a low psychosocial risk had significantly worse mortality than other groups. Additionally, there was no correlation between risk score and complications, except GI bleeds, which were significantly higher in patients with lower scores. Given the smaller number of patients who had higher psychosocial risk scores (scores 3 and 4), further studies are required to better understand this association.
S447
Purpose: Severe left ventricular (LV) dysfunction often presents with left ventricular thrombi (LVT). Data on patients with LVT who receive a left ventricular assist device (LVAD) are scarce. We aimed to analyze the comparative diagnostic value of a pre-implant transthoracic echocardiogram (TTE) for LVT detection against the intraoperative findings at LVAD implantation. Methods: We reviewed patient characteristics, TTE images, transesophageal echocardiographic images, intraoperative findings and pathology reports from the Center for Advanced Heart Failure Data Registry from May 2012 to August 2018. 299 patients received their first LVAD in this period, 238 of them had an LVAD implanted with the use of cardiopulmonary bypass (CPB), and 61 underwent operations without the use of CPB. In all patients who had CPB during their operation, the left ventricle was intraoperatively visually explored. We analyzed the results of 233 patients who had complete data sets. Results: Preoperative TTE identified LVT in 23 of the 233 patients (9.9%); 15 patients (6.4 %) had LVT confirmed via intraventricular visualization. Most of the LVTs were located in the LV apex. Of the 15 patients with visual LVT confirmation, the preoperative TTEs identified an LVT on all but one case. Thus, preoperative TTEs of LVT had a high sensitivity (93%) and specificity (96%), as well as high positive (61%) and negative predictive values (99.5%). In patients with preoperatively identified LVT, all thrombi were removed during LVAD implantation. As compared to those without, patients with LVT were younger (44 § 17 vs. 56 § 13 y, p=0.007) and had a lower prevalence of arterial hypertension (50% vs 92%, p<0.001), hyperlipidemia (38% vs. 74%, p=0.003) and implantable cardioverter-defibrillator (38% vs 74%, p=0.001). Conclusion: This is the largest and most complete study to assess TTE accuracy compared with intraoperative findings in LVAD patients. TTE is a reliable method for the assessment of LVT before LVAD implantation.
1129 Deep Y-Descent in Right Atrial Waveforms is Associated with RV Dysfunction and Worse Outcome in LVAD Patients T. Imamura, A. Nguyen, D. Nitta, S. Kalantari, B. Smith, J. Raikhelkar, N. Narang, B. Chung, I. Ebong, L. Holzhauser, T. Fujino, C. Juricek, P. Combs, D. Onsager, T. Song, T. Ota, V. Jeevanandam, G. Kim, G. Sayer and N. Uriel. University of Chicago, Chicago, IL. Purpose: Right atrial waveform provides diagnostic and clinical information in heart failure patients. Notably, the y-descent (Figure 1A) may provide information about right ventricular systolic and diastolic function. We aimed to investigate the clinical implication of right atrial waveform in LVAD patients. Methods: Patients underwent right heart catheterization (RHC) at 6 months following LVAD implantation and were followed for 1 year afterwards. Impact of a deep y-descent (>3 mmHg) on echocardiographic RA and RV function and clinical outcomes were investigated. Results: 56 LVAD patients (mean age 56.2 years, 77% male) underwent RHC. Patients with post-LVAD deep y-descent (N = 22 [39%]) had increased right ventricular size and worse right ventricular function (Table 1A). The patients with deep y-descent had higher rates of GI bleeding (1.10 vs. 0.32 event/year), stroke (0.28 vs. 0.0 event/year), and heart failure readmissions (0.57 vs. 0.12 events/year) compared to those without (p <0.05 for all; Figure 1B). Conclusion: Deep y-descent of the right atrial waveform during LVAD support is associated with impaired right ventricular function and worse clinical outcomes.
1130 SIPAT Scores Do Not Correlate with Outcomes in Patients with Ventricular Assist Devices K.L. Morris,1 S. Wagner,1 Y. Reddy,2 C. Salerno,1 A. Ravichandran,1 R. Garcia-Cortes,1 A. Patel,1 S. Plotner,1 J. Hart,1 K. Neawedde,1 M.N. Walsh,1 and S.P. Chaudhry.1 1St. Vincent Heart Center of Indiana, Indianapolis, IN; and the 2The Mayo Clinic, Rochester, MN. Purpose: The psychosocial evaluation is of paramount importance when evaluating a patient’s ability to be successful with left ventricular assist device (LVAD) therapy. Current guidelines recommend a “detailed psychosocial evaluation” but do not give any recommendations regarding the use of a specific clinical tool. The Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) has been shown to predict both the psychosocial and medical outcomes in patients post-transplant; however, studies examining its utility in LVAD patients are limited. Methods: We performed a single center, retrospective analysis, of 82 consecutive patients who underwent LVAD implantation from May 2017 to September 2018. Patients were classified into two groups based on a validated SIPAT cutoff score of < 21 as “good” or ≥ 21 as a “minimally acceptable” candidate. A time-to-event analysis was performed to examine a composite outcome of death or re-admission for heart failure (HF), bleeding, infection, or stroke. Each component of the composite outcome was also assessed individually.
S448
The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
Results: Of the 82 patients, 46 (56%) had a score < 21, while 36 (44%) had a score ≥ 21. There were no differences in baseline characteristics including age (58 vs 56, p=0.5), gender (Male: 85% vs 72%, p=0.2), INTERMACS class (3 vs 3, p=0.9), EF (18% vs 17%, p=0.4), GFR (71 vs 66, p=0.4), median days on LVAD support (138 vs 164, p=0.9), or device type. There was no difference in the composite outcome of death or readmission for HF, bleeding, infection, or stroke [Figure 1], or any of the individual components between those with SIPAT scores < 21 versus ≥ 21. Conclusion: Unlike cardiac transplant, the SIPAT score was not predictive of medical outcomes in patients undergoing LVAD therapy. A patient’s underlying biologic effects may influence outcomes more than their psychosocial aspects. Prospective studies should be considered to further explore the validity of the SIPAT score in patients undergoing LVAD implantation.
within the first year was 2.5 § 2.6, and mean number of days to first readmission was 80 § 91. Those with less than a high school education were 55% more likely to experience an adverse event (driveline infection, bacteremia, stroke, hemolysis, GI bleed, other bleed) compared to those with a graduate level education (p < 0.05), but showed no difference in mortality or readmission rates. There was no statistically significant difference in 30day mortality, 1-year mortality, all-cause mortality, days to first readmission, number of readmissions within 1-year, and adverse events based on remaining aforementioned psychosocial risk factors. Conclusion: These results suggest that certain psychosocial factors may not influence mortality or adverse event rates after VAD implantation. Although, education level impacted adverse event rates, further delineation is required. A larger sample size is needed to elucidate exactly which psychosocial characteristics affect VAD outcomes.
1132 Lower Pre-Implantation Psychosocial Risk Scores Do Not Correlate with Better Survival Following Left Ventricular Assist Device (LVAD) Placement N. Grigoryan, L. Brobst, H. Zhao and E. Hamad. Temple University School of Medicine, Philadelphia, PA.
Figure 1
Freedom From Composite Endpoint by SIPAT Score.
1131 Psychosocial Characteristics and Outcomes in Patients with Ventricular Assist Device C. Morreale,1 R. Paliga,2 S. Kothari,1 K. Meehan,2 L. Coyle,2 M. Morack,2 S. Pauwaa,2 G. Macaluso,2 A. Joshi,2 C. Sciamanna,2 A. Tatooles,3 P. Pappas,3 W. Cotts,2 and A. Andrade.2 1Medicine, UIC/ Advocate Christ Medical Center, Oak Lawn, IL; 2Cardiology, Advocate Christ Medical Center, Oak Lawn, IL; and the 3Cardiovascular and Thoracic Surgery, Advocate Christ Medical Center, Oak Lawn, IL. Purpose: Patient selection for durable ventricular assist device (VAD) involves a comprehensive medical and psychosocial evaluation. Although there are guidelines for evaluation of medical comorbidities, psychosocial risk assessment remains somewhat subjective. There is ongoing concern that patients may be denied VAD due to perceived high-risk psychosocial characteristics that may not impact survival after VAD implantation. The purpose of this study was to evaluate the patient psychosocial risk profile and its impact on outcomes after VAD implantation. Methods: This study was a single center, retrospective analysis of 93 patients who underwent durable VAD implantation at Advocate Christ Medical Center in 2016. Psychosocial factors on outcomes were evaluated using the Student’s t-test, Fischer’s exact test, and one-way analysis of variance. Results: Of 93 patients, mean age was 55 § 13 years, 73% were males, 46% were African American, 69% had non-ischemic cardiomyopathy, and 60% received destination therapy. Most prevalent psychosocial factors were: 27% had a pre-existing psychiatric diagnosis, 53% were not married, 22% had no children, 11% lived alone, 19% did not complete a high school education, 26% were chronically unemployed, 55% formerly abused tobacco, 13% formerly abused alcohol, and 24% formerly abused illicit drug. Mean days on device was 589 § 321, mean number of readmissions
Purpose: The assessment of psychosocial risk is an important component in the selection of appropriate candidates for LVAD implementation, however the influence on disease outcome remains poorly studied. In this study, we evaluated the effects of psychosocial risk on mortality, complications, and recurrent admissions. Methods: We performed a retrospective chart review of patients with refractory systolic heart failure who underwent LVAD placement between 2009 and 2018 (N=94). The psychosocial risk, ranging low to high (0-4), was determined through assessment of finances, support system, understanding, compliance, substance abuse, mental health, adjustment, and cognition. The primary outcome was overall survival. Secondary outcomes were development of driveline infections, GI bleeds, other bleeds, stroke, thrombus, and readmissions. Results: The mean age of patients was 57 years, 74% being male. At the end of 2 years, there were 30 deaths (31.9%). At 6, 12, and 24 months, the patients with the lowest psychosocial risk (score 0) had the highest mortality (P=0.043). The number of psychosocial risk factors that each patient had did not affect survival (P=0.21). For secondary outcomes, psychosocial risk did not correlate with development of strokes, thrombi, other bleeds, or readmissions. Patients with higher risk scores developed less GI bleeds than those with lower scores (P=0.018). Conclusion: We found that lower psychosocial risk scores did not correlate with better survival in patients who received an LVAD. However, patients with a low psychosocial risk had significantly worse mortality than other groups. Additionally, there was no correlation between risk score and complications, except GI bleeds, which were significantly higher in patients with lower scores. Given the smaller number of patients who had higher psychosocial risk scores (scores 3 and 4), further studies are required to better understand this association.