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Predictors of Change in Mitral Regurgitation Severity after Left Ventricular Assist Device Implantation
Abstracts significant baseline demographic differences between groups, specifically age, sex, INTERMACS profile, aetiology, short term support use, concomitant surgery or RVAD use. The median age for all patients was 53.5 years. Patient follow up years was 61.6 for HM3 and 72.6 for HM2/HVAD. The KM estimates of survival at 2 years were 91.8% and 74.5% respectively, p=0.05. Numbers at risk are shown in the graph. Only 4 patients died with HM3 during follow up. Conclusion: Despite the caveats of historical comparison and relatively small numbers, we have experienced a trend towards improved survival in patients implanted with the Heartmate 3. This is despite no obvious differences in patient selection or adjustment to our follow up protocols.
887 INTERMACS Profile Does Not Predict Required Flow Rate of CF-LVAD at Discharge A. Critsinelis,1 H. Lamba,1 S. Oberton,1 F. Cheema,1 A. Civitello,2 R. Delgado,1 A. Nair,1 A. Shafii,1 G. Loor,1 T. Rosengart,1 O. Frazier,1 and J. Morgan.1 1Division of Cardiothoracic Transplantation and Mechanical Circulatory Support, Texas Heart Institute at Baylor College of Medicine, Houston, TX; and the 2Baylor College of Medicine, Houston, TX. Purpose: Recent studies involving partial-support ventricular assist device (VADs) have suggested INTERMACS Profiles may be used as a means of identifying patients with less severe heart failure who require lower flow rates. We explore which preoperative factors are predictive of continuous-flow left VAD (CF-LVAD) flow requirements at discharge. Methods: Retrospective review of 206 patients who underwent primary implantation of CF-LVAD from May 2013 through August 2017 at our center and survived to discharge. We performed step-wise multiple linear regression analysis on preoperative factors to identify factors that predicted CF-LVAD flow rates at the time of discharge. Results: Of the 206 patients in our study, 27 (13.1%) were INTERMACS Profile 1, 53 (25.7%) were Profile 2, 95 (46.1%) were Profile 3, 14 were Profile 4, and 17 (6.8%) were Profile 5-7. Mean flow rates at discharge were 5.3§1.3, 5.3§1.6, 4.9§1.3, 5.3§1.2, and 5.8§ 1.0 L/min, respectively. Linear regression analysis showed INTERMACS Profile was not correlated with LVAD flow (p=0.73). Age (Regression Coefficient [RC] = -0.03, p=0.009), body surface area (BSA; RC = 0.23, p=0.03), creatinine (RC = 0.40, p=0.02) and mean right atrial pressure (RC = 0.05, p=0.02) were significantly correlated with higher flow rates (Table). Conclusion: INTERMACS Profile was not a predictor of required flow rates for patients on CF-LVAD support at the time of discharge. Younger age, higher BSA, and preoperative creatinine and mean right atrial pressure predicted greater flow requirements. Further studies are warranted to devise predictive models of CF-LVAD flow requirements.
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888 Hypoalbuminemia in Patients Post LVAD Implantation C. Falls, M.K. Rayens and M. Guglin. University of Kentucky, Lexington, KY. Purpose: Hypoalbuminemia is a prognostic indicator in patients with heart failure but few studies have examined low albumin levels in patients after left ventricular assist device (LVAD) implantation. The purpose of this study was to examine the association between heart failure medications (ACE-inhibitors, beta blockers, aldosterone antagonists, diuretics) and subsequent albumin measurement post LVAD implantation. Methods: We retrospectively analyzed patients who had LVAD implantation between 2010 and 2016. RM ANOVA was used for the analysis of albumin and NT-proBNP. The first analysis used 390 observations of albumin over one year. We examined to see if patients were started on heart failure medications at any time point (baseline to 1 year post LVAD implant) would there be an improvement in albumin. A post-hoc comparison of measures was done for further analysis. Results: Results showed that albumin decreased from baseline (3.19 mg/ dl) (before the surgery) to one week (2.62 mg/dl) post LVAD implant, but then increased over one year (3.69 mg/dl) reaching significance at 1 month (3.23 mg/dl) post LVAD implant. Pairwise comparison noted significance at all measures except from baseline to 3 months and 6 months to 1 year. Use of ACE-inhibitors was the only pharmacologic factor associated with the improvement of albumin over time. None of the other medications were significant. Conclusion: Albumin increases after the LVAD implantation and reached steady normal values by 3 months after surgery. Low preoperative albumin should not be a basis for denying an LVAD. ACEi inhibitors contribute to improvement in serum albumin levels post LVAD implantation, while other guideline directed medications do not contribute.
Type 3 Tests of fixed effects for albumin, medications and Time Factors ACEi ARB Beta Blocker Aldosterone Diuretics Time
P value 0.0010 06820 0.7517 0.7688 0.9354 <.0001
889 Predictors of Change in Mitral Regurgitation Severity after Left Ventricular Assist Device Implantation W. Lin,1 J. Bullen,2 E. Soltesz,3 J. Estep,1 W. Tang,1 M. Sabe,4 E. Joyce,1 and D. Kwon.5 1Section of Heart Failure and Cardiac Transplantation, Cleveland Clinic, Cleveland, OH; 2Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH; 3Department of Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH; 4Beth Israel Deaconess Medical Center, Boston, MA; and the 5Section of Cardiovascular Imaging, Cleveland Clinic, Cleveland, OH.
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The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
Purpose: Right ventricular dysfunction (RVD) and mitral regurgitation (MR) are associated with poor outcomes after left ventricular assist device (LVAD) implantation, and residual MR post-implantation may be associated with poor RV outcomes. We sought to assess predictors of change in MR in patients implanted with continuous flow (CF) LVADs. Methods: 286 patients implanted with CF-LVADs between Jan 2011 - Dec 2015 were analyzed. Demographic, laboratory, clinical and hemodynamic data were obtained from electronic records. Echocardiograms within 3months prior to and within 3-months after surgery were reviewed. A total of 35 potential predictors of change in MR severity pre and post LVAD underwent initial univariable analysis. Variables with p<0.10 were included in the multivariable analysis. Results: Mean age was 57 (§ 12) years, 84% were male, bean LVEF was 17 (§ 6.4) %, and indexed left ventricular end diastolic volume (LVEDVi) was 130 (§ 61) ml/m2. For changes in MR post-op, age, LVEDVi, indexed left atrial volume, degree of pre-op MR, diabetes mellitus, CKD, INTERMACS level, cardiac output, cardiac index, RV stroke work index, sphericity index, average mitral annular diameter, tenting area and coaptation length were identified. On multivariable analysis, LVEDVi and degree of pre-op MR were significant predictors (p = 0.010 and <0.001). Conclusion: For changes in degree of MR, higher pre-operative LVEDVi was associated with worse MR post-surgery, and more severe pre-op MR was associated with improvement in degree of MR post-operatively. These findings suggest pre-implant echocardiographtic assessment of LV size and MR severity can identify patients at increased risk of post-LVAD significant MR. Further analysis is needed to verify the findings of this exploratory study and to determine the effect on clinical outcomes.
associated mortality. One group died of bleeding and repeated infections with a longer survival while the second group died very early following renal and respiratory complications.
890 Delineating Pathways to Death by Multisystem Organ Failure in Patients with a Left Ventricular Assist Device (LVAD) L. Seese,1 F. Movahedi,2 J. Antaki,3 R. Padman,4 S. Murali,5 Y. Zhang,6 A. Kilic,1 C. Sciortino,1 M. Keebler,1 and R. Kormos.1 1Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA; 2Department of Electrical and Computer Engineering, University of Pittsburgh, Pittsburgh, PA; 3Meinig School of Biomedical Engineering, Cornell University, New York, NY; 4The H. John Heinz III College of Information Systems and Public Policy, Carnegie Mellon University, Pittsburgh, PA; 5Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, PA; and the 6Weill Cornell Medical, Cornell University, New York, NY. Purpose: Multisystem organ failure (MOF) is the second leading cause of death in patients undergoing LVAD therapy. In actuality, MOF is a composite of adverse events (AEs) rather than a singular diagnosis. The objective of this study is to identify the key AEs preceding mortality attributed to MOF. Methods: We analyzed 3,765 AE’s in 554 patients (2006-to-2015) with a continuous flow LVAD whose death was reported due to MOF in the INTERMACS database. For each patient (pt), all AEs that preceded the endpoint death were identified and chronologically ordered into sequences. Hierarchical clustering, a machine learning algorithm for clustering, was used to create a descriptive model of the proportions of each adverse event sequence antecedent to MOF (Figure 1). Results: Two major groups of adverse event sequences were identified: Group 1 (118 pts, 1,461 AEs) and Group 2 (436 pts, 2,304 AEs). Group 1 (Grp1) was temporally distinguished from Group 2 (Grp2) by having a longer median time to death (10 months vs 2 months) and a greater median number of AEs per pt (11/ pt vs 5/pt). In both groups, the most common AEs preceding death were renal and respiratory failure (86% Grp1 and 75% Grp2). Unlike Grp2, Grp1 had more prolonged sequences of recurrent bleeding (66% of pts) originating mainly from the GI tract (51%). Grp 1 also had recurrent infections in 65% of pts that were categorized as bacterial pneumonia in 32%. Furthermore, the predominant sequence in Grp1 that led to MOF was bleeding-to-infection-to-death in 83% of the pt’s AE sequences, whereas MOF most commonly (62%) followed renal failure or respiratory failure, in Grp2. Conclusion: This study used a state of the art machine learning approach to identify two predominant types and sequences of AEs that incite MOF
891 External Assessment of EUROMACS Right-Sided Heart Failure Risk Score H. Shah,1 T. Murray,2 A. El Rafei,3 J. Schultz,1 T. Thenappan,1 T. Alexy,1 R. John,4 C. Martin,1 M. Pritzker,1 and R. Cogswell.1 1Cardiology, University of Minnesota, Minneapolis, MN; 2 Biostatistics, University of Minnesota, Minneapolis, MN; 3Internal Medicine, University of Minnesota, Minneapolis, MN; and the 4 Cardiothoracic Surgery, University of Minnesota, Minneapolis, MN. Purpose: The EUROMACS Right-Sided Heart Failure Risk Score was developed to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. The performance of this model outside the derivation cohort has not been tested. Methods: EUROMACS Right-Sided Heart Failure Risk Scores were calculated and assessed as predictors of post-operative RVF in a single center continuous flow (CF) LVAD cohort (n=451). Only patients with complete data for risk score calculation and RVF determination were included in the analysis (n = 254). RVF was defined as RVAD within 30 days, continuous inotropic support ≥ 14 days, or inhaled pulmonary vasodilatory use for > 48 hours after LVAD implantation. Results: Thirty-nine percent of patients (100/254) had post-operative RVF, however only 9% (23/254) required prolonged inotropic support and 5% (12/254) required RVAD placement. Development of RVF after LVAD was associated with a 45% increase the hazards rate of death on LVAD support (HR 1.45, 95 % CI 0.98-2.2, p =0.066), however this was not statistically significant. The increase in mortality associated with RVF was largely driven by patients who required RVAD support (HR 4.6, 95 % CI 2.3- 9.1, p <0.001). Two of the predictors included in the EUROMACS Right Sided Heart Failure Risk Score were not predictive of RVF in this dataset (hemoglobin, p=0.3, right atrial pressure to pulmonary capillary wedge pressure ratio, p=0.4). The area under the curve for EUROMACS Right-Sided Heart Failure Risk Score to predict RVF was 58% (95 % CI 52-66%). Conclusion: The EUROMACS Right-Sided Heart Failure Risk Score had poor discrimination in this LVAD dataset. These findings further emphasize the difficulty of predicting RVF after LVAD placement. Further work is required to enhance our understanding pre- LVAD right ventricular physiology and to accurately risk stratify patients.
887 INTERMACS Profile Does Not Predict Required Flow Rate of CF-LVAD at Discharge A. Critsinelis,1 H. Lamba,1 S. Oberton,1 F. Cheema,1 A. Civitello,2 R. Delgado,1 A. Nair,1 A. Shafii,1 G. Loor,1 T. Rosengart,1 O. Frazier,1 and J. Morgan.1 1Division of Cardiothoracic Transplantation and Mechanical Circulatory Support, Texas Heart Institute at Baylor College of Medicine, Houston, TX; and the 2Baylor College of Medicine, Houston, TX. Purpose: Recent studies involving partial-support ventricular assist device (VADs) have suggested INTERMACS Profiles may be used as a means of identifying patients with less severe heart failure who require lower flow rates. We explore which preoperative factors are predictive of continuous-flow left VAD (CF-LVAD) flow requirements at discharge. Methods: Retrospective review of 206 patients who underwent primary implantation of CF-LVAD from May 2013 through August 2017 at our center and survived to discharge. We performed step-wise multiple linear regression analysis on preoperative factors to identify factors that predicted CF-LVAD flow rates at the time of discharge. Results: Of the 206 patients in our study, 27 (13.1%) were INTERMACS Profile 1, 53 (25.7%) were Profile 2, 95 (46.1%) were Profile 3, 14 were Profile 4, and 17 (6.8%) were Profile 5-7. Mean flow rates at discharge were 5.3§1.3, 5.3§1.6, 4.9§1.3, 5.3§1.2, and 5.8§ 1.0 L/min, respectively. Linear regression analysis showed INTERMACS Profile was not correlated with LVAD flow (p=0.73). Age (Regression Coefficient [RC] = -0.03, p=0.009), body surface area (BSA; RC = 0.23, p=0.03), creatinine (RC = 0.40, p=0.02) and mean right atrial pressure (RC = 0.05, p=0.02) were significantly correlated with higher flow rates (Table). Conclusion: INTERMACS Profile was not a predictor of required flow rates for patients on CF-LVAD support at the time of discharge. Younger age, higher BSA, and preoperative creatinine and mean right atrial pressure predicted greater flow requirements. Further studies are warranted to devise predictive models of CF-LVAD flow requirements.
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888 Hypoalbuminemia in Patients Post LVAD Implantation C. Falls, M.K. Rayens and M. Guglin. University of Kentucky, Lexington, KY. Purpose: Hypoalbuminemia is a prognostic indicator in patients with heart failure but few studies have examined low albumin levels in patients after left ventricular assist device (LVAD) implantation. The purpose of this study was to examine the association between heart failure medications (ACE-inhibitors, beta blockers, aldosterone antagonists, diuretics) and subsequent albumin measurement post LVAD implantation. Methods: We retrospectively analyzed patients who had LVAD implantation between 2010 and 2016. RM ANOVA was used for the analysis of albumin and NT-proBNP. The first analysis used 390 observations of albumin over one year. We examined to see if patients were started on heart failure medications at any time point (baseline to 1 year post LVAD implant) would there be an improvement in albumin. A post-hoc comparison of measures was done for further analysis. Results: Results showed that albumin decreased from baseline (3.19 mg/ dl) (before the surgery) to one week (2.62 mg/dl) post LVAD implant, but then increased over one year (3.69 mg/dl) reaching significance at 1 month (3.23 mg/dl) post LVAD implant. Pairwise comparison noted significance at all measures except from baseline to 3 months and 6 months to 1 year. Use of ACE-inhibitors was the only pharmacologic factor associated with the improvement of albumin over time. None of the other medications were significant. Conclusion: Albumin increases after the LVAD implantation and reached steady normal values by 3 months after surgery. Low preoperative albumin should not be a basis for denying an LVAD. ACEi inhibitors contribute to improvement in serum albumin levels post LVAD implantation, while other guideline directed medications do not contribute.
Type 3 Tests of fixed effects for albumin, medications and Time Factors ACEi ARB Beta Blocker Aldosterone Diuretics Time
P value 0.0010 06820 0.7517 0.7688 0.9354 <.0001
889 Predictors of Change in Mitral Regurgitation Severity after Left Ventricular Assist Device Implantation W. Lin,1 J. Bullen,2 E. Soltesz,3 J. Estep,1 W. Tang,1 M. Sabe,4 E. Joyce,1 and D. Kwon.5 1Section of Heart Failure and Cardiac Transplantation, Cleveland Clinic, Cleveland, OH; 2Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH; 3Department of Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH; 4Beth Israel Deaconess Medical Center, Boston, MA; and the 5Section of Cardiovascular Imaging, Cleveland Clinic, Cleveland, OH.
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The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
Purpose: Right ventricular dysfunction (RVD) and mitral regurgitation (MR) are associated with poor outcomes after left ventricular assist device (LVAD) implantation, and residual MR post-implantation may be associated with poor RV outcomes. We sought to assess predictors of change in MR in patients implanted with continuous flow (CF) LVADs. Methods: 286 patients implanted with CF-LVADs between Jan 2011 - Dec 2015 were analyzed. Demographic, laboratory, clinical and hemodynamic data were obtained from electronic records. Echocardiograms within 3months prior to and within 3-months after surgery were reviewed. A total of 35 potential predictors of change in MR severity pre and post LVAD underwent initial univariable analysis. Variables with p<0.10 were included in the multivariable analysis. Results: Mean age was 57 (§ 12) years, 84% were male, bean LVEF was 17 (§ 6.4) %, and indexed left ventricular end diastolic volume (LVEDVi) was 130 (§ 61) ml/m2. For changes in MR post-op, age, LVEDVi, indexed left atrial volume, degree of pre-op MR, diabetes mellitus, CKD, INTERMACS level, cardiac output, cardiac index, RV stroke work index, sphericity index, average mitral annular diameter, tenting area and coaptation length were identified. On multivariable analysis, LVEDVi and degree of pre-op MR were significant predictors (p = 0.010 and <0.001). Conclusion: For changes in degree of MR, higher pre-operative LVEDVi was associated with worse MR post-surgery, and more severe pre-op MR was associated with improvement in degree of MR post-operatively. These findings suggest pre-implant echocardiographtic assessment of LV size and MR severity can identify patients at increased risk of post-LVAD significant MR. Further analysis is needed to verify the findings of this exploratory study and to determine the effect on clinical outcomes.
associated mortality. One group died of bleeding and repeated infections with a longer survival while the second group died very early following renal and respiratory complications.
890 Delineating Pathways to Death by Multisystem Organ Failure in Patients with a Left Ventricular Assist Device (LVAD) L. Seese,1 F. Movahedi,2 J. Antaki,3 R. Padman,4 S. Murali,5 Y. Zhang,6 A. Kilic,1 C. Sciortino,1 M. Keebler,1 and R. Kormos.1 1Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA; 2Department of Electrical and Computer Engineering, University of Pittsburgh, Pittsburgh, PA; 3Meinig School of Biomedical Engineering, Cornell University, New York, NY; 4The H. John Heinz III College of Information Systems and Public Policy, Carnegie Mellon University, Pittsburgh, PA; 5Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, PA; and the 6Weill Cornell Medical, Cornell University, New York, NY. Purpose: Multisystem organ failure (MOF) is the second leading cause of death in patients undergoing LVAD therapy. In actuality, MOF is a composite of adverse events (AEs) rather than a singular diagnosis. The objective of this study is to identify the key AEs preceding mortality attributed to MOF. Methods: We analyzed 3,765 AE’s in 554 patients (2006-to-2015) with a continuous flow LVAD whose death was reported due to MOF in the INTERMACS database. For each patient (pt), all AEs that preceded the endpoint death were identified and chronologically ordered into sequences. Hierarchical clustering, a machine learning algorithm for clustering, was used to create a descriptive model of the proportions of each adverse event sequence antecedent to MOF (Figure 1). Results: Two major groups of adverse event sequences were identified: Group 1 (118 pts, 1,461 AEs) and Group 2 (436 pts, 2,304 AEs). Group 1 (Grp1) was temporally distinguished from Group 2 (Grp2) by having a longer median time to death (10 months vs 2 months) and a greater median number of AEs per pt (11/ pt vs 5/pt). In both groups, the most common AEs preceding death were renal and respiratory failure (86% Grp1 and 75% Grp2). Unlike Grp2, Grp1 had more prolonged sequences of recurrent bleeding (66% of pts) originating mainly from the GI tract (51%). Grp 1 also had recurrent infections in 65% of pts that were categorized as bacterial pneumonia in 32%. Furthermore, the predominant sequence in Grp1 that led to MOF was bleeding-to-infection-to-death in 83% of the pt’s AE sequences, whereas MOF most commonly (62%) followed renal failure or respiratory failure, in Grp2. Conclusion: This study used a state of the art machine learning approach to identify two predominant types and sequences of AEs that incite MOF
891 External Assessment of EUROMACS Right-Sided Heart Failure Risk Score H. Shah,1 T. Murray,2 A. El Rafei,3 J. Schultz,1 T. Thenappan,1 T. Alexy,1 R. John,4 C. Martin,1 M. Pritzker,1 and R. Cogswell.1 1Cardiology, University of Minnesota, Minneapolis, MN; 2 Biostatistics, University of Minnesota, Minneapolis, MN; 3Internal Medicine, University of Minnesota, Minneapolis, MN; and the 4 Cardiothoracic Surgery, University of Minnesota, Minneapolis, MN. Purpose: The EUROMACS Right-Sided Heart Failure Risk Score was developed to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. The performance of this model outside the derivation cohort has not been tested. Methods: EUROMACS Right-Sided Heart Failure Risk Scores were calculated and assessed as predictors of post-operative RVF in a single center continuous flow (CF) LVAD cohort (n=451). Only patients with complete data for risk score calculation and RVF determination were included in the analysis (n = 254). RVF was defined as RVAD within 30 days, continuous inotropic support ≥ 14 days, or inhaled pulmonary vasodilatory use for > 48 hours after LVAD implantation. Results: Thirty-nine percent of patients (100/254) had post-operative RVF, however only 9% (23/254) required prolonged inotropic support and 5% (12/254) required RVAD placement. Development of RVF after LVAD was associated with a 45% increase the hazards rate of death on LVAD support (HR 1.45, 95 % CI 0.98-2.2, p =0.066), however this was not statistically significant. The increase in mortality associated with RVF was largely driven by patients who required RVAD support (HR 4.6, 95 % CI 2.3- 9.1, p <0.001). Two of the predictors included in the EUROMACS Right Sided Heart Failure Risk Score were not predictive of RVF in this dataset (hemoglobin, p=0.3, right atrial pressure to pulmonary capillary wedge pressure ratio, p=0.4). The area under the curve for EUROMACS Right-Sided Heart Failure Risk Score to predict RVF was 58% (95 % CI 52-66%). Conclusion: The EUROMACS Right-Sided Heart Failure Risk Score had poor discrimination in this LVAD dataset. These findings further emphasize the difficulty of predicting RVF after LVAD placement. Further work is required to enhance our understanding pre- LVAD right ventricular physiology and to accurately risk stratify patients.