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Influence of MELD (Model of End-Stage Liver Disease)_XI (eXcluding INR) on Pediatric Post-Heart Transplant (HT) Outcomes
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The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014
6( 10) The Effect of Medication Regimens on Cardiac Allograft Vasculopathy in Pediatric Heart Transplant Recipients B.S. Moffett ,1 B.J. Hong,2 S.W. Denfield,2 T.J. Humlicek,1 A.G. Cabrera,2 J.F. Price,2 W.J. Dreyer,2 A. Jeewa.2 1Texas Children’s Hospital, Houston, TX; 2Baylor College of Medicine, Houston, TX. Purpose: Cardiac allograft vasculopathy (CAV) is an important cause of graft failure in heart transplant (HTx) recipients. The purpose of this study was to identify the effect of medication regimens (MR) on the development of CAV in pediatric HTx recipients. Methods: Patients (pts) < 19 yrs of age whose first transplant was between 1996 and 2012 at Texas Children’s Hospital were included in the study. Pts MR were followed to 1 of 3 endpoints: date of first CAV diagnosis, retransplantation (RTx), or death. CAV was determined by angiography/imaging or pathology. MR data included: cyclosporine, tacrolimus, mycophenolate mofetil (MMF), sirolimus, prednisone, statin, beta-blockers and angiotensin converting enzyme inhibitors (ACEi) use. MR in those that developed CAV was compared to pts that did not develop CAV. Pts were excluded if death occurred prior to first clinic visit, not transplanted at our institution, had multi-organ transplantation, or RTx. Statistical analysis included univariate and multivariate hazard models. Results: Of the 148 pts identified, 57% were males, with a median age of 3.2 yrs (0.1 - 18.4) at HTx. Graft loss occurred in 27% (n= 40) and CAV was present in 24% (n= 35) pts. Median time to CAV was 5.52 yrs (1.0 - 12.3). No difference was seen in pts who developed CAV to those who did not with respect to age at HTx, sex, or CMV status. Of those who developed CAV, 97% were on steroids compared to 78% without CAV (p= 0.01) and 26% who developed CAV were on MMF compared to 60% without CAV (p= 0.01). Multivariate Hazard ratios (HR) showed that statins and MMF were protective from the development of CAV (HR: 0.39 CI: 0.18-0.89; p= 0.02 and HR: 0.45 CI: 0.2-0.98, p= 0.04) (Figure 1). Prior sirolimus, type of calcineurin inhibitor, or beta-blocker/ACEi use did not appear to be protective for the development of CAV. Conclusion: Prior sirolimus use or calcineurin inhibitor type did not effect the development of CAV. However, the use of statins and MMF suggested a decreased risk of developing CAV in pediatric HTx.
6( 11) Influence of MELD (Model of End-Stage Liver Disease)_XI (eXcluding INR) on Pediatric Post-Heart Transplant (HT) Outcomes E.C. DePasquale , L. Reardon, A. Nsair, M. Deng, J. Alejos. UCLA, Los Angeles, CA. Purpose: Liver dysfunction increases post-surgical morbidity and mortality. MELD-XI has been evaluated in ambulatory heart failure patients and in those receiving VAD support in a single center. Use of MELD-XI in a pediatric post-HT population has not been previously reported. Methods: 5711 HT recipients were identified from UNOS (1987-2011) and stratified by MELD-XI score > = 17 (n= 1918) or < 17 (n= 3793) calculated using creatinine and bilirubin at time of transplant. Exclusions: age< 18, re-HT & lost to follow up, missing creatinine and bilirubin. Survival was censored at 12y. Multivariate Cox proportional hazard regression analysis was adjusted for age, sex, DM, race, ischemic time, dialysis, life support, VAD use, wait time & HLA mismatch.
Results: MELD-XI > = 17 was associated with younger age (p< 0.001), less prior cardiac surgery (p< 0.001), younger donor age (p< 0.001), less VAD use (p< 0.001) and increased ventilator use (p< 0.001) with a shorter wait time (p= 17 were more likely to be listed as status 2 (30% vs 24%, p< 0.001). Survival (1, 5 & 10y) was: MELD-XI < 17 (88, 73, 59%) & MELD-XI > = 17 (76, 61, 48%) (Figure). Unadjusted HR (compared to MELD-XI < 17) for all-cause mortality was 1.51 (CI 1.39-1.66). Multivariate analysis yielded a HR of 1.53 (CI 1.37-1.70). Conclusion: Survival is significantly reduced post-HT in patients with MELD-XI > = 17. Prospective study is warranted as MELD-XI may provide insight into patient selection in the pediatric population.
6( 12) Impact of Mechanical Support on Quality of Life Measures Over Time Is There a Differential Response Based Upon Indication? J.J. Teuteberg ,1 M. McNulty,2 J. Holtz,1 N. Kunz,1 K. Lockard,1 E. Dunn,1 C. Bermudez,1 J.K. Bhama,1 M.A. Shullo,3 R. Kormos,1 M. Dew.2 1Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, PA; 2Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA; 3Pharmacy and Therapeutics, University of Pittsburgh, Pittsburgh, PA. Purpose: Quality of life (QoL) is an important outcome in patients with continuous flow left ventricular assist devices (CF LVAD) as both bridge to transplant (BTT) and destination therapy (DT), particularly with implantation in less ill patients. However, there are few detailed data on the differential impact of CF LVAD on QoL between BTT and DT over time with QoL instruments. Methods: All CF LVAD from 1/08 to 10/13 at a single institution, who consented to QoL assessments were studied. The SF-36 and Minnesota Living with Heart Failure (MLHF) questionnaires were administered at 1, 3, 6, 12 months post implant. Results: There were 106 CF VADs: 56 HeartMateII, 38 HVAD, 11 VentrAssist, 1 Jarvik. Patient demographics: age 55 years, male 84%, white 79%, ischemic 51%, DT 43%, mean duration of support 387 days. Overall and for the BTT and DT groups separately there were significant improvements in QoL from month 1 through 12 in 5 of the 8 domains of the SF-36 (figure 1). Domains of physical well-being showed the largest changes. BTT patients had similar SF-36 scores to DT with the exception of Role: Emotional (76.6 v. 59.8, p= 0.05) and Vitality (41.1 v. 29.3, p= 0.01) at month 1; Physical functioning (53.4 v. 40.6, p= 0.02) at 3 months and (64.3 v. 48.0, p= 0.03) at 6 months. There were also significant improvements in the MLHF questionnaires for overall score (58.9 v. 40.2 v. 37.7 v. 39.1), Physical (25.5 v. 17.1 v. 15.4 v. 16.6), and Emotional (9.8 v. 7.1 v. 8.1 v. 8.0) at months 1, 3, 6, and 12 respectively (p< 0.05 for all). BTT patients had significantly lower MLHF scores than DT patients at months 1 and 6. Conclusion: During the first 12 months of support with CF LVAD there is an overall increase in QoL as assessed by the SF-36 and MLHF questionnaires with the greatest impact on physical well-being and less improvement in emotional QoL. Despite a typically greater burden of co-morbidities and older age, there is a surprisingly similar magnitude and pattern to the improvement in QoL for both DT and BTT.
The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014
6( 10) The Effect of Medication Regimens on Cardiac Allograft Vasculopathy in Pediatric Heart Transplant Recipients B.S. Moffett ,1 B.J. Hong,2 S.W. Denfield,2 T.J. Humlicek,1 A.G. Cabrera,2 J.F. Price,2 W.J. Dreyer,2 A. Jeewa.2 1Texas Children’s Hospital, Houston, TX; 2Baylor College of Medicine, Houston, TX. Purpose: Cardiac allograft vasculopathy (CAV) is an important cause of graft failure in heart transplant (HTx) recipients. The purpose of this study was to identify the effect of medication regimens (MR) on the development of CAV in pediatric HTx recipients. Methods: Patients (pts) < 19 yrs of age whose first transplant was between 1996 and 2012 at Texas Children’s Hospital were included in the study. Pts MR were followed to 1 of 3 endpoints: date of first CAV diagnosis, retransplantation (RTx), or death. CAV was determined by angiography/imaging or pathology. MR data included: cyclosporine, tacrolimus, mycophenolate mofetil (MMF), sirolimus, prednisone, statin, beta-blockers and angiotensin converting enzyme inhibitors (ACEi) use. MR in those that developed CAV was compared to pts that did not develop CAV. Pts were excluded if death occurred prior to first clinic visit, not transplanted at our institution, had multi-organ transplantation, or RTx. Statistical analysis included univariate and multivariate hazard models. Results: Of the 148 pts identified, 57% were males, with a median age of 3.2 yrs (0.1 - 18.4) at HTx. Graft loss occurred in 27% (n= 40) and CAV was present in 24% (n= 35) pts. Median time to CAV was 5.52 yrs (1.0 - 12.3). No difference was seen in pts who developed CAV to those who did not with respect to age at HTx, sex, or CMV status. Of those who developed CAV, 97% were on steroids compared to 78% without CAV (p= 0.01) and 26% who developed CAV were on MMF compared to 60% without CAV (p= 0.01). Multivariate Hazard ratios (HR) showed that statins and MMF were protective from the development of CAV (HR: 0.39 CI: 0.18-0.89; p= 0.02 and HR: 0.45 CI: 0.2-0.98, p= 0.04) (Figure 1). Prior sirolimus, type of calcineurin inhibitor, or beta-blocker/ACEi use did not appear to be protective for the development of CAV. Conclusion: Prior sirolimus use or calcineurin inhibitor type did not effect the development of CAV. However, the use of statins and MMF suggested a decreased risk of developing CAV in pediatric HTx.
6( 11) Influence of MELD (Model of End-Stage Liver Disease)_XI (eXcluding INR) on Pediatric Post-Heart Transplant (HT) Outcomes E.C. DePasquale , L. Reardon, A. Nsair, M. Deng, J. Alejos. UCLA, Los Angeles, CA. Purpose: Liver dysfunction increases post-surgical morbidity and mortality. MELD-XI has been evaluated in ambulatory heart failure patients and in those receiving VAD support in a single center. Use of MELD-XI in a pediatric post-HT population has not been previously reported. Methods: 5711 HT recipients were identified from UNOS (1987-2011) and stratified by MELD-XI score > = 17 (n= 1918) or < 17 (n= 3793) calculated using creatinine and bilirubin at time of transplant. Exclusions: age< 18, re-HT & lost to follow up, missing creatinine and bilirubin. Survival was censored at 12y. Multivariate Cox proportional hazard regression analysis was adjusted for age, sex, DM, race, ischemic time, dialysis, life support, VAD use, wait time & HLA mismatch.
Results: MELD-XI > = 17 was associated with younger age (p< 0.001), less prior cardiac surgery (p< 0.001), younger donor age (p< 0.001), less VAD use (p< 0.001) and increased ventilator use (p< 0.001) with a shorter wait time (p= 17 were more likely to be listed as status 2 (30% vs 24%, p< 0.001). Survival (1, 5 & 10y) was: MELD-XI < 17 (88, 73, 59%) & MELD-XI > = 17 (76, 61, 48%) (Figure). Unadjusted HR (compared to MELD-XI < 17) for all-cause mortality was 1.51 (CI 1.39-1.66). Multivariate analysis yielded a HR of 1.53 (CI 1.37-1.70). Conclusion: Survival is significantly reduced post-HT in patients with MELD-XI > = 17. Prospective study is warranted as MELD-XI may provide insight into patient selection in the pediatric population.
6( 12) Impact of Mechanical Support on Quality of Life Measures Over Time Is There a Differential Response Based Upon Indication? J.J. Teuteberg ,1 M. McNulty,2 J. Holtz,1 N. Kunz,1 K. Lockard,1 E. Dunn,1 C. Bermudez,1 J.K. Bhama,1 M.A. Shullo,3 R. Kormos,1 M. Dew.2 1Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, PA; 2Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA; 3Pharmacy and Therapeutics, University of Pittsburgh, Pittsburgh, PA. Purpose: Quality of life (QoL) is an important outcome in patients with continuous flow left ventricular assist devices (CF LVAD) as both bridge to transplant (BTT) and destination therapy (DT), particularly with implantation in less ill patients. However, there are few detailed data on the differential impact of CF LVAD on QoL between BTT and DT over time with QoL instruments. Methods: All CF LVAD from 1/08 to 10/13 at a single institution, who consented to QoL assessments were studied. The SF-36 and Minnesota Living with Heart Failure (MLHF) questionnaires were administered at 1, 3, 6, 12 months post implant. Results: There were 106 CF VADs: 56 HeartMateII, 38 HVAD, 11 VentrAssist, 1 Jarvik. Patient demographics: age 55 years, male 84%, white 79%, ischemic 51%, DT 43%, mean duration of support 387 days. Overall and for the BTT and DT groups separately there were significant improvements in QoL from month 1 through 12 in 5 of the 8 domains of the SF-36 (figure 1). Domains of physical well-being showed the largest changes. BTT patients had similar SF-36 scores to DT with the exception of Role: Emotional (76.6 v. 59.8, p= 0.05) and Vitality (41.1 v. 29.3, p= 0.01) at month 1; Physical functioning (53.4 v. 40.6, p= 0.02) at 3 months and (64.3 v. 48.0, p= 0.03) at 6 months. There were also significant improvements in the MLHF questionnaires for overall score (58.9 v. 40.2 v. 37.7 v. 39.1), Physical (25.5 v. 17.1 v. 15.4 v. 16.6), and Emotional (9.8 v. 7.1 v. 8.1 v. 8.0) at months 1, 3, 6, and 12 respectively (p< 0.05 for all). BTT patients had significantly lower MLHF scores than DT patients at months 1 and 6. Conclusion: During the first 12 months of support with CF LVAD there is an overall increase in QoL as assessed by the SF-36 and MLHF questionnaires with the greatest impact on physical well-being and less improvement in emotional QoL. Despite a typically greater burden of co-morbidities and older age, there is a surprisingly similar magnitude and pattern to the improvement in QoL for both DT and BTT.