- Email: [email protected]
Longitudinal Holistic Profiling of the Lung Transplant Microbiome
http://www.jhltonline.org
ABSTRACTS 1 Physician and Parent Perceptions of End-of-Life Experience in Children with Advanced Heart Disease E. Morell,1 J. Wolfe,2 S. Ziniel,3 R. Thiagarajan,4 P. Lang,4 H. Cheng,4 T. Kulik,4 L. Smoot,4 E.D. Blume.4 1Harvard Medical School, Boston, MA; 2Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA; 3Pediatrics, Boston Children’s Hospital, Boston, MA; 4Cardiology, Boston Children’s Hospital, Boston, MA. Purpose: To describe and identify associations between parent and physician perceptions regarding end-of-life (EOL) care and suffering in children with advanced heart disease (AHD). Methods and Materials: The Survey about Caring for Children with Heart Disease at EOL was developed and mailed to parents of children with AHD who experienced in-hospital deaths between 2007-2009. Patients’ cardiologists were also surveyed. Spearman correlation coefficients and Fisher’s exact tests were performed. Results: There were 31 parent/physician survey pairs. Patient age at death was a median of 6.5 mo (4 d–20yrs); 84% had congenital heart disease. At EOL, 90% of patients were intubated and 30% were on mechanical circulatory support. Length of last hospital stay was 26 d (1-193 d). Cardiologists expected long-term survival at diagnosis in 36% of patients. Nearly 50% of parents and physicians felt that the child had suffered ‘a great deal,’ ‘a lot,’ or ‘somewhat’ at EOL with no association in perceptions between them. While half of parents felt they ‘‘sometimes’’ received conflicting information from different members of the care team, only 25% of physicians felt that parents perceived care team conflict. In 12 of 28 cases, physicians reported that the parents were prepared for the way the child died while the parents reported feeling unprepared. The majority of parents (93%) felt that quality of care during the last month of the child’s life was ‘excellent’ or ‘very good’ compared to only 78% of physicians. Conclusions: Both parents and physicians perceive suffering at EOL in children who die of AHD. Although parents feel quality of care is excellent, physicians overestimate the degree of parent preparedness for their child’s death. There is no association between parent and physician perceptions of the EOL experience. Prospective studies are necessary to improve EOL care for children with AHD.
Methods and Materials: The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as DT in the national INTERMACS registry. Patients were enrolled from Jan - Sep 2010 at 61 US centers and followed for two years. A historical comparison group included patients (n¼133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR) (NEJM 2009;361:2241-51). Survival rates and adverse events for PA were obtained in the INTERMACS registry. Results: Baseline characteristics were similar for PA vs TR. PA patients were 45% INTERMACS profile 1-2, and 28% profile 3. Adverse events in the PA group were similar or lower than TR. The median length of stay after surgery was reduced by 6 days in PA vs TR. Kaplan Meier survival at 2 years was 62% (PA) vs 58% (TR). PA survival at 1 and 2 years was 82⫾5% and 69⫾6% for INTERMACS profiles 4-7 (n¼63) vs 72⫾3% and 60⫾4% for profiles 1-3 (n¼184). Conclusions: Results in a commercial patient care setting for the DT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology post approval has been associated with continued excellent results.
Baseline Characteristics Cohort
AgeZ70 % Male PCWP Albumin sCR
TR (n¼133) 35% PA (n¼247) 33%
80% 83%
Bilirubin Inotropes
24⫾8 3.3⫾0.6 1.6⫾0.6 1.2⫾0.8 77% 24⫾8 3.4⫾0.5 1.6⫾0.6 1.3⫾0.9 80%
Adverse Events and Outcomes
TR PA 1
LOS1 (d)
Bleeding req surg
Isc Stroke2
Hem Stroke2
Device Infection2
1 yr Surv
2 yr Surv
27 21
30% 11%
0.06 0.03
0.07 0.05
0.48 0.22
68⫾4% 76⫾3%
58⫾4% 62⫾3%
Length of stay; 2events/pt-yr
2
3
Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study Using the INTERMACS Registry U.P. Jorde,1 S.S. Khushwaha,2 A.J. Tatooles,3 Y. Naka,1 G. Bhat,3 J.W. Long,4 D. Horstmanshof,4 R.L. Kormos,5 J.J. Teuteberg,5 M.S. Slaughter,6 E.J. Birks,6 D.J. Farrar,7 S.J. Park.2 1Columbia University Medical Center, New York, NY; 2Mayo Clinic, Rochester, MN; 3Advocate Christ Medical Center, Oak Lawn, IL; 4Integris Baptist Medical Center, Oklahoma City, OK; 5University of Pittsburgh Medical Center, Pittsburgh, PA; 6University of Louisville, Louisville, KY; 7 Thoratec Corporation, Pleasanton, CA.
Longitudinal Holistic Profiling of the Lung Transplant Microbiome D. Willner,1 N.A. Ab-Ghani,1 S. Yerkovich,2,3 M.E. Tan,2,3 P.M. Hopkins,2,3 D.C. Chambers,2,3 P. Hugenholtz.1 1Australian Centre for Ecogenomics, University of Queensland, St. Lucia, QLD, Australia; 2 School of Medicine, University of Queensland, Herston, QLD, Australia; 3Queensland Lung Transplant Service, The Prince Charles Hospital, Brisbane, QLD, Australia.
Purpose: A post approval (PA) study for destination therapy (DT) was required by FDA to determine whether results with the HeartMate (HM) II Left Ventricular Assist Device (LVAD) in a commercial setting are comparable to results during the DT multicenter pivotal clinical trial conducted from 2005-2010.
1053-2498/$ - see front matter http://dx.doi.org/10.1016/j.healun.2013.01.002
Purpose: Gut pathologies and oropharyngeal disorders have been implicated in the development of transplant complications, and the sinuses have been shown to be a seeding site for allograft colonization in cystic fibrosis (CF) patients, suggesting a definitive link between microbiota at multiple sites in transplant recipients. We hypothesize that the allograft microbiome will be dynamic over time in response to antibiotic pressures and that microbial populations characteristic of the pre-transplant lung will be maintained at non-respiratory body sites.
Abstracts Methods and Materials: We longitudinally investigated microbial community profiles at multiple body sites in lung transplant recipients (n¼ 31, 16 CF) at time of and within the first year following transplant using barcoded PCR of the universal bacterial marker gene, 16S rRNA, followed by 454 pyrosequencing. Samples included bronchoalveolar lavage fluid (BAL), explanted lung tissue, and nasopharyngeal, oral, and rectal swabs. Sequences were analyzed using the QIIME pipeline. Differences in community profiles were assessed using Unifrac analysis, and longitudinal changes in the microbiome were quantified using the Shannon index. Results: BAL samples showed marked fluctuations in response to antibiotic pressure and a gradual loss of diversity over time, as demonstrated by a significant decrease in the Shannon Index (p¼0.03). Temporal shifts in BAL communities corresponded to similar but staggered changes in the nasopharynx. Unifrac distances indicated that in CF and most Non-CF individuals, microbial populations in explanted lung tissue were most similar to those in the nasopharynx, while oral and gut communities were more representative of body site. Conclusions: The allograft microbiome is dynamic in response not only to antibiotic pressures but also to interactions with microbial populations in the nasopharynx. As opposed to the mouth and gut, the nasal cavity serves as a reservoir for the recipient’s pre-transplant microbiota, which can go on to reinfect the allograft. 4 Hemocompatibility of a Fully Magnetically Levitated Centrifugal LVAD: Results from the DuraHeart Pivotal Trial N. Moazami,1 F. Pagani,2 D. Feldman,3 Y. Naka,4 S. Bailey,5 M. Camacho.6 1Thoracic & Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH; 2University of Michigan, Ann Arbor, MI; 3Abbott Northwestern Hospital, Minneapolis, MN; 4Columbia University, New York, NY; 5Allegheny Hospital, Pittsburgh, PA; 6St. Barnabas Medical Center, Newark, NJ. Purpose: The DuraHeart LVAD is a CF pump with centrifugal design with active magnetic levitation for impellor positioning and passive magnetic coupling of motor and impellor. This design allows for large gaps (250 microns), reducing the potential for high shear stress and blood trauma. The objective of this study was to evaluate the biocompatibility and durability and of this unique centrifugal design. Methods and Materials: The DuraHeart Pivotal trial was a multicenter, prospective, observational, single-arm study for BTT. 63 patients were enrolled and follow up was complete in 100%. Results: Median duration of support was 204 (range 10-1156) days with a total support time of 45 patient-years. Mean LDH values peaked at day 4 and significantly decreased during support (435 ⫾236 and 297⫾142 on day 3 and day 180, respectively) Mean plasma-free hg peaked to 14.8 mg/ dl (⫾10) at day 4 and remained low during the period of support. There were no hemolysis AEs and no de-novo pump thrombosis. 3 cases of pump thrombus ‘‘in transit’’ occured based on current waveform analysis (0.06 events/ patient-year support). Overall 50 pumps were available for analysis and confirmed no pump thrombus. There were 6 (10%) cases of Mag-Lev failure, all secondary to cable wire fractures (0.12 events/ patient-year support). In all cases the patients were hemodynamically stable with the back-up hydrodynamic mode. Five patients underwent successful device exchange and 1 was transplanted. Conclusions: The first trial of a fully magnetically-levitated centrifugal pump demonstrated excellent hemocompatibility assessed by a very low incidence of hemolysis and de-novo pump thrombosis. The Mag-Lev system was reliable and failure was associated with cable fractures. Future designs in full Mag-Lev pumps require improvement in durability of the cable. Full magnetic levitation may have improved blood compatibility compared to existing axial designs with bearing technology or centrifugal designs that rely on primary hydrodynamic levitation. 5 Results of the Registry To EValuate the HeartWare Left Ventricular Assist System (The REVOLVE Registry) M. Strueber,1 R. Larbalestier,2 P. Jansz,3 D. Zimpfer,4 A.E. Fiane,5 S. Tsui,6 A. Simon,7 K. Najarian,8 S. Shueler.9 1HERZZENTRUM Leipzig GmbH, Leipzig, Germany; 2Royal Perth Hospital, Perth,
S11 Australia; 3St. Vincent’s Hospital, Sydney, Australia; 4Medical University Vienna, Vienna, Austria; 5Oslo University Medical Center, Oslo, Norway; 6Papworth Hospital, Cambridge, United Kingdom; 7 Royal Brompton Hospital, London, United Kingdom; 8HeartWare, Inc., Framingham, MA; 9Freeman Hospital, Newcastle, United Kingdom. Purpose: The REVOLVE Registry is an investigator-initiated registry established to collect data on the commercial use of the HeartWares HVAD System in the European Union and Australia. Methods and Materials: REVOLVE is a multi-center, prospective, single arm registry. Each patient is followed to device explant, transplantation or death. Data from the first 242 commercial implants performed between February of 2009 and March 2012 from six centers in Europe (4) and Australia (2) is presented. Final data on the total dataset will be available at the time of presentation. Patients receiving the HeartWare System for both labeled and off-label indications were included. Summary statistics are used to describe patient demographics, adverse events, length of support and outcomes. Results: When compared to the clinical trial supporting CE Mark of the HVAD Pump, changes in patient selection (older mean age, patients younger than 18 year old and more females), as well as an increase in idiopathic cardiomyopathies are evident in the REVOLVE patients. Implants were performed mostly via sternotomy (96%), and thoracotomy in 4%. Implant was for LVAD support in 91% of cases, biventricular support in 7%, and as right ventricular support in o2%. Preliminary adverse events are presented. Duration of support ranged
Complication
EPPY (222 years of support)
Any INTERMACS Bleeding Right Heart Failure Stroke Driveline Infection Sepsis Renal Failure Pump Thrombus - Overall Medically Treated Pump Thrombus Pump Thrombus Treated with Exchange
0.27 0.16 0.09 0.08 0.05 0.03 0.06 0.02 0.04
EPPY¼events per patient year. from 1-1057 days with a mean of 392 days. Transplantation occurred in 22.3% patients, explant for recovery in 0.8%, 19.8% died on support, and 57% remain on the device. The mean duration of support for all patients was 13 months, with transplantation after approximately one year of support. Conclusions: Real world use of the HVAD Pump continues to support the excellent outcomes on the device. 6 Japanese Experience of EVAHEART TM Left Ventricular Assist System S. Saito,1 T. Nishinaka,1 Y. Ichihara,1 M. Komagamine,1 H. Tsukui,1 K. Yamazaki.1 J-MACS Investigators2 1Cardiovascular Surgery, Tokyo Women’s Medical University, Tokyo, Japan; 2J-MACS Investigators, Tokyo, Japan. Purpose: The EVAHEART(Sun Medical Technology Research Co, JAPAN) is centrifugal left ventricular assist system providing highly pulsed flow designed for long-term circulatory support. We report the clinical outcomes of 85 patients implanted with the EVAHEART as a bridge to cardiac transplantation in JAPAN. Methods and Materials: Eighty-five patients with advanced heart failure (INTERMACS profile I-III, eligible for heart transplantation, who was eligible for cardiac transplantation) were implanted with the EVAHEART between 2006 and Oct 2012 in 13 clinical site. Median age was 43 (range: 18-60) and 18 of these patients received the device as a part of the Japanese multi-center clinical trial. Survival analyses and
ABSTRACTS 1 Physician and Parent Perceptions of End-of-Life Experience in Children with Advanced Heart Disease E. Morell,1 J. Wolfe,2 S. Ziniel,3 R. Thiagarajan,4 P. Lang,4 H. Cheng,4 T. Kulik,4 L. Smoot,4 E.D. Blume.4 1Harvard Medical School, Boston, MA; 2Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA; 3Pediatrics, Boston Children’s Hospital, Boston, MA; 4Cardiology, Boston Children’s Hospital, Boston, MA. Purpose: To describe and identify associations between parent and physician perceptions regarding end-of-life (EOL) care and suffering in children with advanced heart disease (AHD). Methods and Materials: The Survey about Caring for Children with Heart Disease at EOL was developed and mailed to parents of children with AHD who experienced in-hospital deaths between 2007-2009. Patients’ cardiologists were also surveyed. Spearman correlation coefficients and Fisher’s exact tests were performed. Results: There were 31 parent/physician survey pairs. Patient age at death was a median of 6.5 mo (4 d–20yrs); 84% had congenital heart disease. At EOL, 90% of patients were intubated and 30% were on mechanical circulatory support. Length of last hospital stay was 26 d (1-193 d). Cardiologists expected long-term survival at diagnosis in 36% of patients. Nearly 50% of parents and physicians felt that the child had suffered ‘a great deal,’ ‘a lot,’ or ‘somewhat’ at EOL with no association in perceptions between them. While half of parents felt they ‘‘sometimes’’ received conflicting information from different members of the care team, only 25% of physicians felt that parents perceived care team conflict. In 12 of 28 cases, physicians reported that the parents were prepared for the way the child died while the parents reported feeling unprepared. The majority of parents (93%) felt that quality of care during the last month of the child’s life was ‘excellent’ or ‘very good’ compared to only 78% of physicians. Conclusions: Both parents and physicians perceive suffering at EOL in children who die of AHD. Although parents feel quality of care is excellent, physicians overestimate the degree of parent preparedness for their child’s death. There is no association between parent and physician perceptions of the EOL experience. Prospective studies are necessary to improve EOL care for children with AHD.
Methods and Materials: The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as DT in the national INTERMACS registry. Patients were enrolled from Jan - Sep 2010 at 61 US centers and followed for two years. A historical comparison group included patients (n¼133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR) (NEJM 2009;361:2241-51). Survival rates and adverse events for PA were obtained in the INTERMACS registry. Results: Baseline characteristics were similar for PA vs TR. PA patients were 45% INTERMACS profile 1-2, and 28% profile 3. Adverse events in the PA group were similar or lower than TR. The median length of stay after surgery was reduced by 6 days in PA vs TR. Kaplan Meier survival at 2 years was 62% (PA) vs 58% (TR). PA survival at 1 and 2 years was 82⫾5% and 69⫾6% for INTERMACS profiles 4-7 (n¼63) vs 72⫾3% and 60⫾4% for profiles 1-3 (n¼184). Conclusions: Results in a commercial patient care setting for the DT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology post approval has been associated with continued excellent results.
Baseline Characteristics Cohort
AgeZ70 % Male PCWP Albumin sCR
TR (n¼133) 35% PA (n¼247) 33%
80% 83%
Bilirubin Inotropes
24⫾8 3.3⫾0.6 1.6⫾0.6 1.2⫾0.8 77% 24⫾8 3.4⫾0.5 1.6⫾0.6 1.3⫾0.9 80%
Adverse Events and Outcomes
TR PA 1
LOS1 (d)
Bleeding req surg
Isc Stroke2
Hem Stroke2
Device Infection2
1 yr Surv
2 yr Surv
27 21
30% 11%
0.06 0.03
0.07 0.05
0.48 0.22
68⫾4% 76⫾3%
58⫾4% 62⫾3%
Length of stay; 2events/pt-yr
2
3
Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study Using the INTERMACS Registry U.P. Jorde,1 S.S. Khushwaha,2 A.J. Tatooles,3 Y. Naka,1 G. Bhat,3 J.W. Long,4 D. Horstmanshof,4 R.L. Kormos,5 J.J. Teuteberg,5 M.S. Slaughter,6 E.J. Birks,6 D.J. Farrar,7 S.J. Park.2 1Columbia University Medical Center, New York, NY; 2Mayo Clinic, Rochester, MN; 3Advocate Christ Medical Center, Oak Lawn, IL; 4Integris Baptist Medical Center, Oklahoma City, OK; 5University of Pittsburgh Medical Center, Pittsburgh, PA; 6University of Louisville, Louisville, KY; 7 Thoratec Corporation, Pleasanton, CA.
Longitudinal Holistic Profiling of the Lung Transplant Microbiome D. Willner,1 N.A. Ab-Ghani,1 S. Yerkovich,2,3 M.E. Tan,2,3 P.M. Hopkins,2,3 D.C. Chambers,2,3 P. Hugenholtz.1 1Australian Centre for Ecogenomics, University of Queensland, St. Lucia, QLD, Australia; 2 School of Medicine, University of Queensland, Herston, QLD, Australia; 3Queensland Lung Transplant Service, The Prince Charles Hospital, Brisbane, QLD, Australia.
Purpose: A post approval (PA) study for destination therapy (DT) was required by FDA to determine whether results with the HeartMate (HM) II Left Ventricular Assist Device (LVAD) in a commercial setting are comparable to results during the DT multicenter pivotal clinical trial conducted from 2005-2010.
1053-2498/$ - see front matter http://dx.doi.org/10.1016/j.healun.2013.01.002
Purpose: Gut pathologies and oropharyngeal disorders have been implicated in the development of transplant complications, and the sinuses have been shown to be a seeding site for allograft colonization in cystic fibrosis (CF) patients, suggesting a definitive link between microbiota at multiple sites in transplant recipients. We hypothesize that the allograft microbiome will be dynamic over time in response to antibiotic pressures and that microbial populations characteristic of the pre-transplant lung will be maintained at non-respiratory body sites.
Abstracts Methods and Materials: We longitudinally investigated microbial community profiles at multiple body sites in lung transplant recipients (n¼ 31, 16 CF) at time of and within the first year following transplant using barcoded PCR of the universal bacterial marker gene, 16S rRNA, followed by 454 pyrosequencing. Samples included bronchoalveolar lavage fluid (BAL), explanted lung tissue, and nasopharyngeal, oral, and rectal swabs. Sequences were analyzed using the QIIME pipeline. Differences in community profiles were assessed using Unifrac analysis, and longitudinal changes in the microbiome were quantified using the Shannon index. Results: BAL samples showed marked fluctuations in response to antibiotic pressure and a gradual loss of diversity over time, as demonstrated by a significant decrease in the Shannon Index (p¼0.03). Temporal shifts in BAL communities corresponded to similar but staggered changes in the nasopharynx. Unifrac distances indicated that in CF and most Non-CF individuals, microbial populations in explanted lung tissue were most similar to those in the nasopharynx, while oral and gut communities were more representative of body site. Conclusions: The allograft microbiome is dynamic in response not only to antibiotic pressures but also to interactions with microbial populations in the nasopharynx. As opposed to the mouth and gut, the nasal cavity serves as a reservoir for the recipient’s pre-transplant microbiota, which can go on to reinfect the allograft. 4 Hemocompatibility of a Fully Magnetically Levitated Centrifugal LVAD: Results from the DuraHeart Pivotal Trial N. Moazami,1 F. Pagani,2 D. Feldman,3 Y. Naka,4 S. Bailey,5 M. Camacho.6 1Thoracic & Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH; 2University of Michigan, Ann Arbor, MI; 3Abbott Northwestern Hospital, Minneapolis, MN; 4Columbia University, New York, NY; 5Allegheny Hospital, Pittsburgh, PA; 6St. Barnabas Medical Center, Newark, NJ. Purpose: The DuraHeart LVAD is a CF pump with centrifugal design with active magnetic levitation for impellor positioning and passive magnetic coupling of motor and impellor. This design allows for large gaps (250 microns), reducing the potential for high shear stress and blood trauma. The objective of this study was to evaluate the biocompatibility and durability and of this unique centrifugal design. Methods and Materials: The DuraHeart Pivotal trial was a multicenter, prospective, observational, single-arm study for BTT. 63 patients were enrolled and follow up was complete in 100%. Results: Median duration of support was 204 (range 10-1156) days with a total support time of 45 patient-years. Mean LDH values peaked at day 4 and significantly decreased during support (435 ⫾236 and 297⫾142 on day 3 and day 180, respectively) Mean plasma-free hg peaked to 14.8 mg/ dl (⫾10) at day 4 and remained low during the period of support. There were no hemolysis AEs and no de-novo pump thrombosis. 3 cases of pump thrombus ‘‘in transit’’ occured based on current waveform analysis (0.06 events/ patient-year support). Overall 50 pumps were available for analysis and confirmed no pump thrombus. There were 6 (10%) cases of Mag-Lev failure, all secondary to cable wire fractures (0.12 events/ patient-year support). In all cases the patients were hemodynamically stable with the back-up hydrodynamic mode. Five patients underwent successful device exchange and 1 was transplanted. Conclusions: The first trial of a fully magnetically-levitated centrifugal pump demonstrated excellent hemocompatibility assessed by a very low incidence of hemolysis and de-novo pump thrombosis. The Mag-Lev system was reliable and failure was associated with cable fractures. Future designs in full Mag-Lev pumps require improvement in durability of the cable. Full magnetic levitation may have improved blood compatibility compared to existing axial designs with bearing technology or centrifugal designs that rely on primary hydrodynamic levitation. 5 Results of the Registry To EValuate the HeartWare Left Ventricular Assist System (The REVOLVE Registry) M. Strueber,1 R. Larbalestier,2 P. Jansz,3 D. Zimpfer,4 A.E. Fiane,5 S. Tsui,6 A. Simon,7 K. Najarian,8 S. Shueler.9 1HERZZENTRUM Leipzig GmbH, Leipzig, Germany; 2Royal Perth Hospital, Perth,
S11 Australia; 3St. Vincent’s Hospital, Sydney, Australia; 4Medical University Vienna, Vienna, Austria; 5Oslo University Medical Center, Oslo, Norway; 6Papworth Hospital, Cambridge, United Kingdom; 7 Royal Brompton Hospital, London, United Kingdom; 8HeartWare, Inc., Framingham, MA; 9Freeman Hospital, Newcastle, United Kingdom. Purpose: The REVOLVE Registry is an investigator-initiated registry established to collect data on the commercial use of the HeartWares HVAD System in the European Union and Australia. Methods and Materials: REVOLVE is a multi-center, prospective, single arm registry. Each patient is followed to device explant, transplantation or death. Data from the first 242 commercial implants performed between February of 2009 and March 2012 from six centers in Europe (4) and Australia (2) is presented. Final data on the total dataset will be available at the time of presentation. Patients receiving the HeartWare System for both labeled and off-label indications were included. Summary statistics are used to describe patient demographics, adverse events, length of support and outcomes. Results: When compared to the clinical trial supporting CE Mark of the HVAD Pump, changes in patient selection (older mean age, patients younger than 18 year old and more females), as well as an increase in idiopathic cardiomyopathies are evident in the REVOLVE patients. Implants were performed mostly via sternotomy (96%), and thoracotomy in 4%. Implant was for LVAD support in 91% of cases, biventricular support in 7%, and as right ventricular support in o2%. Preliminary adverse events are presented. Duration of support ranged
Complication
EPPY (222 years of support)
Any INTERMACS Bleeding Right Heart Failure Stroke Driveline Infection Sepsis Renal Failure Pump Thrombus - Overall Medically Treated Pump Thrombus Pump Thrombus Treated with Exchange
0.27 0.16 0.09 0.08 0.05 0.03 0.06 0.02 0.04
EPPY¼events per patient year. from 1-1057 days with a mean of 392 days. Transplantation occurred in 22.3% patients, explant for recovery in 0.8%, 19.8% died on support, and 57% remain on the device. The mean duration of support for all patients was 13 months, with transplantation after approximately one year of support. Conclusions: Real world use of the HVAD Pump continues to support the excellent outcomes on the device. 6 Japanese Experience of EVAHEART TM Left Ventricular Assist System S. Saito,1 T. Nishinaka,1 Y. Ichihara,1 M. Komagamine,1 H. Tsukui,1 K. Yamazaki.1 J-MACS Investigators2 1Cardiovascular Surgery, Tokyo Women’s Medical University, Tokyo, Japan; 2J-MACS Investigators, Tokyo, Japan. Purpose: The EVAHEART(Sun Medical Technology Research Co, JAPAN) is centrifugal left ventricular assist system providing highly pulsed flow designed for long-term circulatory support. We report the clinical outcomes of 85 patients implanted with the EVAHEART as a bridge to cardiac transplantation in JAPAN. Methods and Materials: Eighty-five patients with advanced heart failure (INTERMACS profile I-III, eligible for heart transplantation, who was eligible for cardiac transplantation) were implanted with the EVAHEART between 2006 and Oct 2012 in 13 clinical site. Median age was 43 (range: 18-60) and 18 of these patients received the device as a part of the Japanese multi-center clinical trial. Survival analyses and