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283: Post Transplant Survival Following Support with a Continuous Flow Left Ventricular Assist Device
The Journal of Heart and Lung Transplantation Volume 28, Number 2S
Abstracts
283 Post Transplant Survival Following Support with a Continuous Flow Left Ventricular Assist Device R. John1, F.D. Pagani2, Y. Naka3, S.D. Russell4, A.J. Boyle1, C.T. Klodell5, J.G. Rogers6, D.J. Farrar7, O.H. Frazier8 1University of Minnesota, Minneapolis, MN; 2University of Michigan, Ann Arbor; 3Columbia University, New York; 4John Hopkins Hospital, Baltimore; 5University of Florida, Gainesville; 6Duke University, Durham; 7Thoratec Corporation, Pleasanton; 8Texas Heart Institute, Houston Purpose: Continuous flow LVADs have been shown to have excellent survival as a bridge to transplant. However the effects of continuous flow on survival after transplant have not been studied in detail. Methods and Materials: The HeartMate II LVAD was implanted in 459 patients on the transplant waiting list at 35 centers. Mean age was 55 (range 15 – 77), 45% had ischemic etiology, and 23% were females. Survival rates were determined at 30 days and 1 year post-transplant and were also stratified by gender, age, etiology, and body mass index (BMI). Results: Of 459 patients, 236 underwent transplant after a median of 143 days (longest 3.2 years), 87 died (19%), 12 (2.6%) recovered LV function, and 121 (26%) continuing on support. Of those transplanted, 210 and 136 have reached at least 30 days or 1 year post transplant, respectively. The post transplant survival is 96.7% at 30 days and 90.4% at 1 year. There were no differences in survival for gender, age, etiology, or BMI. Conclusions: Post transplant survival (90% at 1 year) after support with a continuous flow LVAD is excellent and at least equivalent to that with conventional transplant. This data supports that these devices should be the standard of care as a bridge-to transplant. Transplanted patients who have reached 30 days or 1 year since transplantation
All Pts Gender Age
Etiology BMI
Males Females ⱖ 60 50-59 ⬍50 Ischemic Non-ischemic ⬍ 20 20-29.9 ⱖ 30
LVAD days median (longest)
Post-Transplant Survival (no. pts at interval) 30 day*
1 year*
143 137 162 141 159 130 149 138 125 134 172
96.7% 97.1% 94.4% 96.2% 97.4% 96.3% 97.8% 95.7% 90.0% 98.3% 95.3%
90.4% 92.6% 82.1% 91.2% 91.5% 89.1% 91.7% 89.5% 93.3% 88.3% 92.9%
(3.2 (3.2 (1.7 (1.7 (2.1 (3.2 (1.7 (3.2 (1.4 (3.2 (2.1
yr) yr) yr) yr) yr) yr) yr) yr) yr) yr) yr)
(210) (172) (36) (53) (77) (80) (93) (117) (20) (121) (64)
(136) (108) (28) (34) (47) (55) (60) (76) (15) (77) (42)
* all comparisons are non-significant at 30 days and at 1 year
284 Pre-Implant Risk for VAD’s and VAD AE’s Influences the Onset of Adverse Events (AE’s) Following Cardiac Transplantation (CTX) and Ultimate Survival S. Rayappa, J.J. Teuteberg, M.P. Siegenthaler, J. Kay, E. Genovese, M. Simon, M.A. Dew, J.J. Bhama, K.L. Lockard, R.L. Kormos University of Pittsburgh, Pittsburgh, PA Purpose: The use of a VAD is often considered an independent risk for survival following CTX due to the inherent risk of the pre-implant status and AE’s while on the VAD. We examined if pre-implant risk and VAD AE’s also had an influence in the incidence of AE’s after CTX and post-CTX mortality. Methods and Materials: We reviewed all post-CTX AE’s and survival in 144 patients between 03/26/1996 to 12/19/2007 which accounted
S165
for 60% of those who received a VAD. All AE’s were adjudicated and INTERMACS definitions were used. Results: Actuarial CTX survival in this group of pts was 51% at 10 years. Univariate analysis of survival showed that 10 year survival was affected by prevad diabetes (p⬍0.005), postcardiotomy syndrome (p⬍0.04), and hypertension history (p⬍0.01). The presence of respiratory failure (p⬍0.005) or infection (p⬍ 0.05), on the VAD affected 10 year CTX survival. urgency of VAD implant did not effect subsequent CTX outcome. Post-CTX bleeding was stratified by device with the Heartmate XVE having the least (90% free at 30 days) and Thoratec PVAD and Novacor being 55% free at 30 days. VAD’s also carried extended risk for neurologic events post-CTX with the least seen in the rotary VAD’s (90%free at 2 years) and the highest in the Novacor (60% free at 2 years)(p⬍0.05). The incidence of post CTX AE’s was also affected by AE’s on the VAD. Incidence of CTX neurological events was higher at 1 year in those with infection on the VAD (32%) vs in those without (14%) (p⬍0.02). They were also more common in pts who had VAD bleeding AE’s (35% vs 12%; p⬍0.01). Infections post-CTX occurred more frequently in those with VAD infections (p⬍0.01), VAD respiratory complications (p⬍0.02) and in those who had a neurological AE on the VAD (p⬍0.003). Conclusions: Pre-implant VAD risk influences post CTX outcome both in survival and incidence of post CTX adverse events. In addition, the occurrence of AE’s while on the VAD result in reduced post CTX survival and an increased incidence of AE’s in the transplant recipient. 285 Prognostic Impact of Non-HLA Antibodies Targeting Vascular Receptors for the Development of Microvasculopathy in Biopsy after Heart Transplantation N.E. Hiemann1, C. Renner1, R. Meyer1, E. Wellnhofer2, C. Schoenemann3, H. Heidecke4, R. Hetzer1, D. Dragun5 1 Deutsches Herzzentrum Berlin, Berlin, Germany; 2Deutsches Herzzentrum Berlin, Berlin, Germany; 3Institute of Transfusion Medicine, Humboldt University Berlin Charite´, Berlin, Germany; 4 Celltrend GmbH, Berlin, Germany; 5Humboldt University Berlin Charite´, Berlin, Germany Purpose: Non-HLA antibodies (Abs) are an increasingly recognized component of the immune response to organ transplants. We tested the impact of non-HLA Abs targeting vascular receptors on rejection and microvasculopathy (MVP) in heart transplant (HTx) recipients. Methods and Materials: We studied prospectively 30 HTx pts (22 men, mean age 48 yrs) at 24 hrs, 2 weeks, 1 month, 6 months and 1 yr post HTx for presence of IgG directed against endothelin-1 type A (ETAR-Ab) and angiotensin II type 1 (AT1R-Ab) receptors (elevated level cut-off ⬎10 U/L) by means of cell ELISA. Endomyocardial biopsies were obtained at 1 month (Bx1⫽20) and 1 yr (Bx2⫽20). Histology (H&E) served for diagnosis of cellular rejection [ISHLT] and MVP. Immunohistochemical reactions for smooth muscle cells were performed (alpha-actin, clone 1A4, Dako) in order to detect microvascular remodeling (medial disease) associated with MVP. Results: At 1 month and 1 yr post HTx, cellular rejection was found in 40% and 13% of biopsies, and stenotic MVP was present in 37% and 40% of biopsies, respectively. During the first year post HTx, 50% of pts presented elevated levels of ETAR-Abs and 53% high levels of AT1R-Abs. Pts with high AT1R-Abs presented more often with cellular rejection than pts without (77% vs. 33%, p⫽0.06). Increased density of muscularized microvessels was found at 1 month post HTx in pts with high ETAR-Abs (88% vs. 44%, p⫽0.06) and at 1 yr post HTx in pts with high AT1R-Abs (80% vs. 27%, p⫽0.05). CRP pre-HTx was higher in pts with elevated ETAR-Abs (3.9⫾0.9 vs. 0.9⫾0.3 mg/dL, p⫽0.01) or AT1R-Abs (3.8⫾0.7 vs. 0.8⫾0.3 mg/dL, p⫽0.01), suggesting a permissive role of inflammation.
Abstracts
283 Post Transplant Survival Following Support with a Continuous Flow Left Ventricular Assist Device R. John1, F.D. Pagani2, Y. Naka3, S.D. Russell4, A.J. Boyle1, C.T. Klodell5, J.G. Rogers6, D.J. Farrar7, O.H. Frazier8 1University of Minnesota, Minneapolis, MN; 2University of Michigan, Ann Arbor; 3Columbia University, New York; 4John Hopkins Hospital, Baltimore; 5University of Florida, Gainesville; 6Duke University, Durham; 7Thoratec Corporation, Pleasanton; 8Texas Heart Institute, Houston Purpose: Continuous flow LVADs have been shown to have excellent survival as a bridge to transplant. However the effects of continuous flow on survival after transplant have not been studied in detail. Methods and Materials: The HeartMate II LVAD was implanted in 459 patients on the transplant waiting list at 35 centers. Mean age was 55 (range 15 – 77), 45% had ischemic etiology, and 23% were females. Survival rates were determined at 30 days and 1 year post-transplant and were also stratified by gender, age, etiology, and body mass index (BMI). Results: Of 459 patients, 236 underwent transplant after a median of 143 days (longest 3.2 years), 87 died (19%), 12 (2.6%) recovered LV function, and 121 (26%) continuing on support. Of those transplanted, 210 and 136 have reached at least 30 days or 1 year post transplant, respectively. The post transplant survival is 96.7% at 30 days and 90.4% at 1 year. There were no differences in survival for gender, age, etiology, or BMI. Conclusions: Post transplant survival (90% at 1 year) after support with a continuous flow LVAD is excellent and at least equivalent to that with conventional transplant. This data supports that these devices should be the standard of care as a bridge-to transplant. Transplanted patients who have reached 30 days or 1 year since transplantation
All Pts Gender Age
Etiology BMI
Males Females ⱖ 60 50-59 ⬍50 Ischemic Non-ischemic ⬍ 20 20-29.9 ⱖ 30
LVAD days median (longest)
Post-Transplant Survival (no. pts at interval) 30 day*
1 year*
143 137 162 141 159 130 149 138 125 134 172
96.7% 97.1% 94.4% 96.2% 97.4% 96.3% 97.8% 95.7% 90.0% 98.3% 95.3%
90.4% 92.6% 82.1% 91.2% 91.5% 89.1% 91.7% 89.5% 93.3% 88.3% 92.9%
(3.2 (3.2 (1.7 (1.7 (2.1 (3.2 (1.7 (3.2 (1.4 (3.2 (2.1
yr) yr) yr) yr) yr) yr) yr) yr) yr) yr) yr)
(210) (172) (36) (53) (77) (80) (93) (117) (20) (121) (64)
(136) (108) (28) (34) (47) (55) (60) (76) (15) (77) (42)
* all comparisons are non-significant at 30 days and at 1 year
284 Pre-Implant Risk for VAD’s and VAD AE’s Influences the Onset of Adverse Events (AE’s) Following Cardiac Transplantation (CTX) and Ultimate Survival S. Rayappa, J.J. Teuteberg, M.P. Siegenthaler, J. Kay, E. Genovese, M. Simon, M.A. Dew, J.J. Bhama, K.L. Lockard, R.L. Kormos University of Pittsburgh, Pittsburgh, PA Purpose: The use of a VAD is often considered an independent risk for survival following CTX due to the inherent risk of the pre-implant status and AE’s while on the VAD. We examined if pre-implant risk and VAD AE’s also had an influence in the incidence of AE’s after CTX and post-CTX mortality. Methods and Materials: We reviewed all post-CTX AE’s and survival in 144 patients between 03/26/1996 to 12/19/2007 which accounted
S165
for 60% of those who received a VAD. All AE’s were adjudicated and INTERMACS definitions were used. Results: Actuarial CTX survival in this group of pts was 51% at 10 years. Univariate analysis of survival showed that 10 year survival was affected by prevad diabetes (p⬍0.005), postcardiotomy syndrome (p⬍0.04), and hypertension history (p⬍0.01). The presence of respiratory failure (p⬍0.005) or infection (p⬍ 0.05), on the VAD affected 10 year CTX survival. urgency of VAD implant did not effect subsequent CTX outcome. Post-CTX bleeding was stratified by device with the Heartmate XVE having the least (90% free at 30 days) and Thoratec PVAD and Novacor being 55% free at 30 days. VAD’s also carried extended risk for neurologic events post-CTX with the least seen in the rotary VAD’s (90%free at 2 years) and the highest in the Novacor (60% free at 2 years)(p⬍0.05). The incidence of post CTX AE’s was also affected by AE’s on the VAD. Incidence of CTX neurological events was higher at 1 year in those with infection on the VAD (32%) vs in those without (14%) (p⬍0.02). They were also more common in pts who had VAD bleeding AE’s (35% vs 12%; p⬍0.01). Infections post-CTX occurred more frequently in those with VAD infections (p⬍0.01), VAD respiratory complications (p⬍0.02) and in those who had a neurological AE on the VAD (p⬍0.003). Conclusions: Pre-implant VAD risk influences post CTX outcome both in survival and incidence of post CTX adverse events. In addition, the occurrence of AE’s while on the VAD result in reduced post CTX survival and an increased incidence of AE’s in the transplant recipient. 285 Prognostic Impact of Non-HLA Antibodies Targeting Vascular Receptors for the Development of Microvasculopathy in Biopsy after Heart Transplantation N.E. Hiemann1, C. Renner1, R. Meyer1, E. Wellnhofer2, C. Schoenemann3, H. Heidecke4, R. Hetzer1, D. Dragun5 1 Deutsches Herzzentrum Berlin, Berlin, Germany; 2Deutsches Herzzentrum Berlin, Berlin, Germany; 3Institute of Transfusion Medicine, Humboldt University Berlin Charite´, Berlin, Germany; 4 Celltrend GmbH, Berlin, Germany; 5Humboldt University Berlin Charite´, Berlin, Germany Purpose: Non-HLA antibodies (Abs) are an increasingly recognized component of the immune response to organ transplants. We tested the impact of non-HLA Abs targeting vascular receptors on rejection and microvasculopathy (MVP) in heart transplant (HTx) recipients. Methods and Materials: We studied prospectively 30 HTx pts (22 men, mean age 48 yrs) at 24 hrs, 2 weeks, 1 month, 6 months and 1 yr post HTx for presence of IgG directed against endothelin-1 type A (ETAR-Ab) and angiotensin II type 1 (AT1R-Ab) receptors (elevated level cut-off ⬎10 U/L) by means of cell ELISA. Endomyocardial biopsies were obtained at 1 month (Bx1⫽20) and 1 yr (Bx2⫽20). Histology (H&E) served for diagnosis of cellular rejection [ISHLT] and MVP. Immunohistochemical reactions for smooth muscle cells were performed (alpha-actin, clone 1A4, Dako) in order to detect microvascular remodeling (medial disease) associated with MVP. Results: At 1 month and 1 yr post HTx, cellular rejection was found in 40% and 13% of biopsies, and stenotic MVP was present in 37% and 40% of biopsies, respectively. During the first year post HTx, 50% of pts presented elevated levels of ETAR-Abs and 53% high levels of AT1R-Abs. Pts with high AT1R-Abs presented more often with cellular rejection than pts without (77% vs. 33%, p⫽0.06). Increased density of muscularized microvessels was found at 1 month post HTx in pts with high ETAR-Abs (88% vs. 44%, p⫽0.06) and at 1 yr post HTx in pts with high AT1R-Abs (80% vs. 27%, p⫽0.05). CRP pre-HTx was higher in pts with elevated ETAR-Abs (3.9⫾0.9 vs. 0.9⫾0.3 mg/dL, p⫽0.01) or AT1R-Abs (3.8⫾0.7 vs. 0.8⫾0.3 mg/dL, p⫽0.01), suggesting a permissive role of inflammation.