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Left Ventricle Mechanical Circulatory Support Implantation as Successful Bridge to Transplantation for Patients with Cardiac Cachexia
S372
The Journal of Heart and Lung Transplantation, Vol 35, No 4S, April 2016
1( 038)
The 1-year survival rate of the patients who had an aMI was 73.7% (28/38) and from the surgical patients without aMI was 80.0% (20/25) respectively. Patients with non-ischemic cardiomyopathy had a 1-year survival of 75.0% (6/8) after successful ECMO-therapy. Conclusion: The 1-year mortality of patients with cardiogenic shock, supported with VA ECMO who survived to discharge appears to be moderate. The mortality of patients with cardiogenic shock after successful VA-ECMO treatment seems not to be dependent upon the etiology of the cardiogenic shock.
Interim Results of a Phase II Clinical Trial Comparing Outcomes of Recipients of Lungs Recovered from Uncontrolled Donation After Circulatory Determination of Death Donors (uDCDDs) Assessed by Ex-Vivo Lung Perfusion (EVLP) and CT Scan to Outcomes of Recipients of Lungs from Brain-Dead Donors (BDDs) T.M. Egan ,1 B. Haithcock,1 J. Long,1 K. Birchard,2 J. Lobo,3 P. Stewart,4 J. Blackwell,1 D. Yuan,1 C. Thys,5 D. Karb,6 S. Miller,6 M. Hartwig.7 1Surgery, U. North Carolina Sch Med, Chapel Hill, NC; 2Radiology, U. North Carolina Sch Med, Chapel Hill, NC; 3Medicine, U. North Carolina Sch Med, Chapel Hill, NC; 4Biostatistics, U. North Carolina Sch Med Gillings School of Public Health, Chapel Hill, NC; 5Carolina Donor Services, Durham, NC; 6U. North Carolina Sch Med, Chapel Hill, NC; 7Surgery, Duke University School of Medicine, Durham, NC. Summary of Objectives: This clinical trial is designed to show safety and non-inferiority of lung transplant (LTX) with lungs recovered from uDCDDs evaluated by EVLP and ex-vivo CT scan compared to lungs recovered from BDDs. The study began in Sept. 2013, and is scheduled to run until June 30, 2017. Methods: Our organ procurement organization (OPO) began to seek consent for lung recovery for possible LTX from next-of-kin (NOK) of uDCDDs in one urban county. uDCDDs from 4 Emergency Departments (EDs) were added during the first year. Consented recipients at 2 LTX centers in the OPO received whichever lung became available first (uDCDD or BDD), based on blood type, LAS, and size. __ lungs were recovered from uDCDDs. ___ were assessed by EVLP and ex-vivo CT scan. ___ were judged suitable for lung transplant; ___ were transplanted. Outcomes were compared to __ transplanted with lungs recovered from BDDs. Endpoints: Primary outcome measures: Primary Graft Dysfunction (PGD) score at 72 hours and 30-day and one-year survival. Secondary outcome measures: PGD score at 24 hours; mechanical ventilation time; on ventilator or ECMO 7 days after LTX; ICU length of stay (LOS); hospital LOS; requirement for re-intubation; incidence of biopsy proven acute rejection; and incidence of bronchial complications. See Table for results. To date, lungs from 2 uDCDDs were judged suitable for transplant, but no uDCDD lungs have yet been transplanted. Data will be updated before March 23. 1( 039) Successfully Weaned Patients after VA ECMO Due to Cardiogenic Shock: Etiology and 1-Year Survival D. Pabst ,1 A. Ghodsizad,1 A. El-Banayosy,2 B. Soleimani,1 C. Brehm.1 1Heart and Vascular Institute, Penn State Milton S. Hershey Medical Center, Hershey, PA; 2INTEGRIS Baptist Medical Center, Oklahoma City, OK. Purpose: Congestive heart failure is one of the leading causes of hospital admission in adult patients with heart disease. Patients with decompensated cardiac failure clinically present with cardiogenic shock in which a venoarterial extracorporeal membrane oxygenation (VA-ECMO) is often the final treatment option. Methods: In our institution a cohort of 155 patients received VA ECMO for cardiogenic shock between June 2008 and October 2014. 1-year survival, etiology and post-weaning process of these patients were investigated. Results: Out of 155 patients, 83 (53.6%) were able to be weaned from ECMO and were discharged. 66 (79.6%) of the 83 patients survived the first year after ECMO-treatment. 43 (51.8%) of the patients developed cardiogenic shock due to an acute myocardial infarction (aMI) or acute decompensated ischemic cardiomyopathy, of which, 9 underwent coronary artery bypass grafting (CABG) procedure prior to ECMO placement. An additional 25 (30.1%) patients underwent cardiac surgery for other reasons (7 (8.4%) valve surgery, 6 (7.2%) both valve and CABG surgeries, 4 (4.8%) elective CABG surgery, 6 (7.2%) heart transplantation, 1 (1.2%) PFO surgery and 1 (1.2%) myectomy) directly prior to or while showing signs of cardiogenic shock. 8 patients (9.6%) had a non-ischemic cardiomyopathy, 3 patients (3.6%) had a graft failure after heart transplantation and 3 (3.6%) of the patients suffered from pulmonary emboli. Furthermore 1 (1.2%) of the patients had a cardiogenic shock due to a pericardial effusion after stenting a stenosis of the superior vena cava.
1( 040) Left Ventricular Assist Device Placement with Concomitant Ventricular Reconstruction for Aneurysmal Disease J.W. Smith , J.D. Pal, D. Walters, C.M. Mahr, N.A. Mokadam. Univ of Washington, Seattle, WA. Purpose: Left ventricular aneurysms a surgical challenge in patients with advanced heart failure requiring implantation of a left ventricular assist device. We describe our institutional experience with left ventricular reconstruction at the time of LVAD implantation. Methods: The medical records of all patients who underwent LVAD implantation between January 1, 2007 and December 31, 2014 were reviewed and patients with left ventricular aneurysms were identified. Individual records were reviewed to determine perioperative and long-term outcomes. Results: During the study period, five patients were identified with left ventricular aneurysms. One patient had previously undergone a lateral wall linear resection. All five patients had technically successful LVAD implantation, four with concomitant left ventricular reconstruction. Two patients underwent ventriculoplasty with usual apical inflow cannulation. Two patients had anterior Dor procedures with incorporation of the inflow cannula site into the repair. In order to prevent thrombotic complications, aneurysms were resected and all adherent thrombus removed from the left ventricle. Bovine pericardium was used to cover the left ventricular aspect of resected muscle or septum to reduce the likelihood of thrombus formation. One patient suffered a perioperative stroke with poor neurologic recovery, and the family elected to withdraw support. Four of the five patients survived to discharge. Two patients remain on mechanical circulatory support as destination therapy, and two of the patients successfully underwent heart transplantation. Conclusion: Left ventricular aneurysm resection and reconstruction during LVAD implantation is technically feasible and may be necessary for appropriate inflow cannula position. The operative approach to left ventricular aneurysms needs to individualized for each patient’s particular anatomy, and the LVAD apical cannulation site is determined by the type of repair required.
1( 041) Left Ventricle Mechanical Circulatory Support Implantation as Successful Bridge to Transplantation for Patients with Cardiac Cachexia M. Hegarova ,1 I. Malek,1 V. Melenovsky,1 Z. Dorazilova,1 J. Kettner,1 J. Maly,2 I. Netuka,2 J. Pirk.2 1Department of Cardiology, IKEM, Prague,
Abstracts S373 Czech Republic; 2Department of Cardiovascular Surgery, IKEM, Prague, Czech Republic. Purpose: Patients with advanced heart failure (AHF) who reach the stage of cardiac cachexia have a poor prognosis. An increase in cardiac output, preferentially by mechanical circulatory support implantation, is the only effective approach for this catabolic stage of AHF. We analyzed outcomes of pts with signs of cardiac cachexia before Heart Mate II (HM II) (Thoratec Corp) implantation in our institution. Methods: From 02/08 to 12/14 150 pts with AHF received the HM II in bridge to transplant indication in our institution. 40 pts (27%) of them were operated in the stage of cardiac cachexia, defined by the presence of significant weight loss (> 6% within 6months) and by presence of abnormal biochemistry: C-reactive protein (CRP) > 5 mg/l or hemoglobin (Hb) < 120 g/l or albumin < 32 g/l. We assessed heart transplantation (HTx) attainment and results in the group of patients with cardiac cachexia (Group A, n= 40) compared with noncachectic group (Group B, n= 110). Results: Pts with cachexia had mean body mass index 22,1 (16,6-31), mean weight loss was 13,3% (6-26%), 36 of them (90%) had CRP > 5 mg/l, 28pts (70%) had Hb < 120 g/l and 25pts (62,5%) had albumin < 32 g/l. Mean albumin level in this group was 30,1g/l (19,6-34,6g/l). Heart transplantation (HTx) was performed in 28pts (70%) from Group A with early mortality 2,5% and in 69 pts (62,7%) from Group B with early mortality 5,45% (for mortality n.s. by chi-square). Mean time between HM II implantation and HTx was 261 days in Group A and 364 days in Group B. We observed normalization of nutritional parameters after HM II implantation in 33 individuals (82,5%), all of them are alive, 27 of them were successfully transplanted. Conclusion: In this paper we present very good results of HM II implantation in patients with advanced heart failure in the stage of cardiac cachexia. We believe that implantation of mechanical circulatory support is the only way to achieve a metabolic condition that allows a successful heart transplantation in these patients. Heart transplantation should be done only after normalization of nutritional parameters and the regression of clinical signs of cachexia. 1( 042) A Novel Combined Endpoint Integrating Quality of Life Can Inform Decisions about VAD in Ambulatory Advanced Heart Failure G.C. Stewart ,1 A.V. Ambardekar,2 M.M. Kittleson,3 M. Palardy,4 A. DeVore,5 J.T. Thibodeau,6 J.J. Teuteberg,7 L.M. Cadaret,8 R.C. FordeMcLean,9 M.M. Mountis,10 S.V. Pamboukian,11 R. Cantor,11 R. Xie,11 L.W. Stevenson.1 1Brigham & Women’s Hospital, Boston, MA; 2University of Colorado Hospitals, Denver, CO; 3Cedars-Sinai Heart Institute, Los Angeles, CA; 4University of Michigan, Ann Arbor, MI; 5Duke University Medical Center, Durham, NC; 6University of Texas Southwestern, Dallas, TX; 7University of Pittsburgh Medical Center, Pittsburgh, PA; 8University of Iowa, Iowa City, IA; 9University of Pennsylvania, Philadelphia, PA; 10Cleveland Clinic, Cleveland, OH; 11University of Alabama Birmingham, Birmingham, AL. Purpose: As ventricular assist devices (VAD) expand into a less advanced heart failure (HF) population, increasing consideration is being given to decreased quality of life (QOL) as well as length of survival. Patients with advanced HF place equal emphasis on QOL and survival when weighing information about VAD, yet no integrated endpoints exist to inform decisionmaking. We explored the use of a novel combined endpoint integrating QOL with standard endpoints to better understand the natural history of ambulatory HF and guide decisions about VAD therapy. Methods: Ambulatory patients on oral medications for chronic systolic HF were enrolled in the MedaMACS registry after ≥ 1 prior hospitalization and at least one other high risk criteria. Comprehensive characteristics including QOL were tracked. Patients were followed for endpoints of death, transplant or VAD. Patients alive on only medical therapy at 6 months received a validated telephone EuroQOL (EQ)-5D questionnaire about generic health-related QOL. An EQ-5D index score utility ≤ 0.5 defined poor QOL and was used to generate a combined endpoint of death, transplant, VAD or poor QOL. Results: Of 150 patients enrolled, mean EF was 20%, 56% were INTERMACS profiles 6/7, 71% had ≥ 2 cardiac hospitalizations in the prior year. By 6 months, 18 patients died, 7 were transplanted, and 9 received a
VAD. Of the remaining cohort on medical therapy who answered EQ-5D at 6 months, an additional 9 (12%) were identified as having EQ-5D ≤ 0.5. Patients with EQ-5D ≤ 0.5 were more likely to express dissatisfaction with HF-related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire compared to EQ-5D > 0.5 (68 vs. 51%, p= 0.04). Baseline features were no different between patients with and without the combined endpoint. Adding poor QOL to death/transplant/VAD generated a 26% relative increase in the number of patients reaching an unfavorable 6 month endpoint (29% total). Conclusion: A combined endpoint integrating EQ-5D can be easily generated to describe unfavorable outcomes for ambulatory patients on medical therapy for HF. Since this endpoint tracks general rather than HF-related QOL, it could increase the statistical power and relevance of comparisons between VAD and medical therapy, but more importantly integrates the outcomes of most interest to patients who are considering VAD. 1( 043) Myocarditis Treated with VA-ECMO: A Single Centers Experience A. Burdorf , S. Varnado, J.L. Balk, T. Ryan, E. Raichlin, H. Vongooru, B. Lowes, R. Zolty, J. Um, H. Merritt-Genore, M. Moulton, A. Siddique. Nebraska Medicine, Omaha, NE. Purpose: Extracorporeal membrane oxygenation (ECMO) is increasingly used for cardiogenic shock from many causes. There is a high mortality in this population; however, picking the right patients for support may lead to improved outcomes. We sought to compare survival in patients with myocarditis with other diagnoses, and to identify variables that might be able to predict outcome. Methods: From our institutional ECMO database, we analyzed laboratory and outcomes data for 61 patients initiated on VA-ECMO to determine whether patients being treated for myocarditis had improved outcomes compared to non-myocarditis patients. We utilized t-test and wilkson-rank sum for parametric and non-parametric data. Results: We analyzed 61 patients supported exclusively with VA-ECMO between September 2006 and October 2015. From those 61 patients, 8 were treated for myocarditis. At 30 days, 5 were successfully weaned from support (63%), 1 was transplanted (12%) and 2 expired (25%). This contrasts with the non-myocarditis cohort, which had a 66% 30-day mortality rate (p= 0.05). The median duration of support was 8 [IQR 4.25; 18.5] days in the myocarditis cohort compared to 3 [IQR 2; 8] days in the overall cohort (p= 0.02). We collected 13 laboratory variables (CBC, sodium, BUN, creatinine, bicarbonate, AST, ALT, total bilirubin and lactic acid) obtained upon ECMO initiation. There were no significant differences found between the above parameters. Based upon this analysis, we were unable to detect laboratory variables that were associated with positive outcomes. Despite longer durations of support, it appears that patients with myocarditis have increased survival at 30 days when compared to patients supported on VA-ECMO for other indications. Conclusion: Patients treated with VA-ECMO for myocarditis have improved survival compared to other indications for VA-ECMO but a larger trial is needed to confirm this single-center data. Pre-implant laboratory parameters were not significantly different between myocarditis and non-myocarditis patients.
The Journal of Heart and Lung Transplantation, Vol 35, No 4S, April 2016
1( 038)
The 1-year survival rate of the patients who had an aMI was 73.7% (28/38) and from the surgical patients without aMI was 80.0% (20/25) respectively. Patients with non-ischemic cardiomyopathy had a 1-year survival of 75.0% (6/8) after successful ECMO-therapy. Conclusion: The 1-year mortality of patients with cardiogenic shock, supported with VA ECMO who survived to discharge appears to be moderate. The mortality of patients with cardiogenic shock after successful VA-ECMO treatment seems not to be dependent upon the etiology of the cardiogenic shock.
Interim Results of a Phase II Clinical Trial Comparing Outcomes of Recipients of Lungs Recovered from Uncontrolled Donation After Circulatory Determination of Death Donors (uDCDDs) Assessed by Ex-Vivo Lung Perfusion (EVLP) and CT Scan to Outcomes of Recipients of Lungs from Brain-Dead Donors (BDDs) T.M. Egan ,1 B. Haithcock,1 J. Long,1 K. Birchard,2 J. Lobo,3 P. Stewart,4 J. Blackwell,1 D. Yuan,1 C. Thys,5 D. Karb,6 S. Miller,6 M. Hartwig.7 1Surgery, U. North Carolina Sch Med, Chapel Hill, NC; 2Radiology, U. North Carolina Sch Med, Chapel Hill, NC; 3Medicine, U. North Carolina Sch Med, Chapel Hill, NC; 4Biostatistics, U. North Carolina Sch Med Gillings School of Public Health, Chapel Hill, NC; 5Carolina Donor Services, Durham, NC; 6U. North Carolina Sch Med, Chapel Hill, NC; 7Surgery, Duke University School of Medicine, Durham, NC. Summary of Objectives: This clinical trial is designed to show safety and non-inferiority of lung transplant (LTX) with lungs recovered from uDCDDs evaluated by EVLP and ex-vivo CT scan compared to lungs recovered from BDDs. The study began in Sept. 2013, and is scheduled to run until June 30, 2017. Methods: Our organ procurement organization (OPO) began to seek consent for lung recovery for possible LTX from next-of-kin (NOK) of uDCDDs in one urban county. uDCDDs from 4 Emergency Departments (EDs) were added during the first year. Consented recipients at 2 LTX centers in the OPO received whichever lung became available first (uDCDD or BDD), based on blood type, LAS, and size. __ lungs were recovered from uDCDDs. ___ were assessed by EVLP and ex-vivo CT scan. ___ were judged suitable for lung transplant; ___ were transplanted. Outcomes were compared to __ transplanted with lungs recovered from BDDs. Endpoints: Primary outcome measures: Primary Graft Dysfunction (PGD) score at 72 hours and 30-day and one-year survival. Secondary outcome measures: PGD score at 24 hours; mechanical ventilation time; on ventilator or ECMO 7 days after LTX; ICU length of stay (LOS); hospital LOS; requirement for re-intubation; incidence of biopsy proven acute rejection; and incidence of bronchial complications. See Table for results. To date, lungs from 2 uDCDDs were judged suitable for transplant, but no uDCDD lungs have yet been transplanted. Data will be updated before March 23. 1( 039) Successfully Weaned Patients after VA ECMO Due to Cardiogenic Shock: Etiology and 1-Year Survival D. Pabst ,1 A. Ghodsizad,1 A. El-Banayosy,2 B. Soleimani,1 C. Brehm.1 1Heart and Vascular Institute, Penn State Milton S. Hershey Medical Center, Hershey, PA; 2INTEGRIS Baptist Medical Center, Oklahoma City, OK. Purpose: Congestive heart failure is one of the leading causes of hospital admission in adult patients with heart disease. Patients with decompensated cardiac failure clinically present with cardiogenic shock in which a venoarterial extracorporeal membrane oxygenation (VA-ECMO) is often the final treatment option. Methods: In our institution a cohort of 155 patients received VA ECMO for cardiogenic shock between June 2008 and October 2014. 1-year survival, etiology and post-weaning process of these patients were investigated. Results: Out of 155 patients, 83 (53.6%) were able to be weaned from ECMO and were discharged. 66 (79.6%) of the 83 patients survived the first year after ECMO-treatment. 43 (51.8%) of the patients developed cardiogenic shock due to an acute myocardial infarction (aMI) or acute decompensated ischemic cardiomyopathy, of which, 9 underwent coronary artery bypass grafting (CABG) procedure prior to ECMO placement. An additional 25 (30.1%) patients underwent cardiac surgery for other reasons (7 (8.4%) valve surgery, 6 (7.2%) both valve and CABG surgeries, 4 (4.8%) elective CABG surgery, 6 (7.2%) heart transplantation, 1 (1.2%) PFO surgery and 1 (1.2%) myectomy) directly prior to or while showing signs of cardiogenic shock. 8 patients (9.6%) had a non-ischemic cardiomyopathy, 3 patients (3.6%) had a graft failure after heart transplantation and 3 (3.6%) of the patients suffered from pulmonary emboli. Furthermore 1 (1.2%) of the patients had a cardiogenic shock due to a pericardial effusion after stenting a stenosis of the superior vena cava.
1( 040) Left Ventricular Assist Device Placement with Concomitant Ventricular Reconstruction for Aneurysmal Disease J.W. Smith , J.D. Pal, D. Walters, C.M. Mahr, N.A. Mokadam. Univ of Washington, Seattle, WA. Purpose: Left ventricular aneurysms a surgical challenge in patients with advanced heart failure requiring implantation of a left ventricular assist device. We describe our institutional experience with left ventricular reconstruction at the time of LVAD implantation. Methods: The medical records of all patients who underwent LVAD implantation between January 1, 2007 and December 31, 2014 were reviewed and patients with left ventricular aneurysms were identified. Individual records were reviewed to determine perioperative and long-term outcomes. Results: During the study period, five patients were identified with left ventricular aneurysms. One patient had previously undergone a lateral wall linear resection. All five patients had technically successful LVAD implantation, four with concomitant left ventricular reconstruction. Two patients underwent ventriculoplasty with usual apical inflow cannulation. Two patients had anterior Dor procedures with incorporation of the inflow cannula site into the repair. In order to prevent thrombotic complications, aneurysms were resected and all adherent thrombus removed from the left ventricle. Bovine pericardium was used to cover the left ventricular aspect of resected muscle or septum to reduce the likelihood of thrombus formation. One patient suffered a perioperative stroke with poor neurologic recovery, and the family elected to withdraw support. Four of the five patients survived to discharge. Two patients remain on mechanical circulatory support as destination therapy, and two of the patients successfully underwent heart transplantation. Conclusion: Left ventricular aneurysm resection and reconstruction during LVAD implantation is technically feasible and may be necessary for appropriate inflow cannula position. The operative approach to left ventricular aneurysms needs to individualized for each patient’s particular anatomy, and the LVAD apical cannulation site is determined by the type of repair required.
1( 041) Left Ventricle Mechanical Circulatory Support Implantation as Successful Bridge to Transplantation for Patients with Cardiac Cachexia M. Hegarova ,1 I. Malek,1 V. Melenovsky,1 Z. Dorazilova,1 J. Kettner,1 J. Maly,2 I. Netuka,2 J. Pirk.2 1Department of Cardiology, IKEM, Prague,
Abstracts S373 Czech Republic; 2Department of Cardiovascular Surgery, IKEM, Prague, Czech Republic. Purpose: Patients with advanced heart failure (AHF) who reach the stage of cardiac cachexia have a poor prognosis. An increase in cardiac output, preferentially by mechanical circulatory support implantation, is the only effective approach for this catabolic stage of AHF. We analyzed outcomes of pts with signs of cardiac cachexia before Heart Mate II (HM II) (Thoratec Corp) implantation in our institution. Methods: From 02/08 to 12/14 150 pts with AHF received the HM II in bridge to transplant indication in our institution. 40 pts (27%) of them were operated in the stage of cardiac cachexia, defined by the presence of significant weight loss (> 6% within 6months) and by presence of abnormal biochemistry: C-reactive protein (CRP) > 5 mg/l or hemoglobin (Hb) < 120 g/l or albumin < 32 g/l. We assessed heart transplantation (HTx) attainment and results in the group of patients with cardiac cachexia (Group A, n= 40) compared with noncachectic group (Group B, n= 110). Results: Pts with cachexia had mean body mass index 22,1 (16,6-31), mean weight loss was 13,3% (6-26%), 36 of them (90%) had CRP > 5 mg/l, 28pts (70%) had Hb < 120 g/l and 25pts (62,5%) had albumin < 32 g/l. Mean albumin level in this group was 30,1g/l (19,6-34,6g/l). Heart transplantation (HTx) was performed in 28pts (70%) from Group A with early mortality 2,5% and in 69 pts (62,7%) from Group B with early mortality 5,45% (for mortality n.s. by chi-square). Mean time between HM II implantation and HTx was 261 days in Group A and 364 days in Group B. We observed normalization of nutritional parameters after HM II implantation in 33 individuals (82,5%), all of them are alive, 27 of them were successfully transplanted. Conclusion: In this paper we present very good results of HM II implantation in patients with advanced heart failure in the stage of cardiac cachexia. We believe that implantation of mechanical circulatory support is the only way to achieve a metabolic condition that allows a successful heart transplantation in these patients. Heart transplantation should be done only after normalization of nutritional parameters and the regression of clinical signs of cachexia. 1( 042) A Novel Combined Endpoint Integrating Quality of Life Can Inform Decisions about VAD in Ambulatory Advanced Heart Failure G.C. Stewart ,1 A.V. Ambardekar,2 M.M. Kittleson,3 M. Palardy,4 A. DeVore,5 J.T. Thibodeau,6 J.J. Teuteberg,7 L.M. Cadaret,8 R.C. FordeMcLean,9 M.M. Mountis,10 S.V. Pamboukian,11 R. Cantor,11 R. Xie,11 L.W. Stevenson.1 1Brigham & Women’s Hospital, Boston, MA; 2University of Colorado Hospitals, Denver, CO; 3Cedars-Sinai Heart Institute, Los Angeles, CA; 4University of Michigan, Ann Arbor, MI; 5Duke University Medical Center, Durham, NC; 6University of Texas Southwestern, Dallas, TX; 7University of Pittsburgh Medical Center, Pittsburgh, PA; 8University of Iowa, Iowa City, IA; 9University of Pennsylvania, Philadelphia, PA; 10Cleveland Clinic, Cleveland, OH; 11University of Alabama Birmingham, Birmingham, AL. Purpose: As ventricular assist devices (VAD) expand into a less advanced heart failure (HF) population, increasing consideration is being given to decreased quality of life (QOL) as well as length of survival. Patients with advanced HF place equal emphasis on QOL and survival when weighing information about VAD, yet no integrated endpoints exist to inform decisionmaking. We explored the use of a novel combined endpoint integrating QOL with standard endpoints to better understand the natural history of ambulatory HF and guide decisions about VAD therapy. Methods: Ambulatory patients on oral medications for chronic systolic HF were enrolled in the MedaMACS registry after ≥ 1 prior hospitalization and at least one other high risk criteria. Comprehensive characteristics including QOL were tracked. Patients were followed for endpoints of death, transplant or VAD. Patients alive on only medical therapy at 6 months received a validated telephone EuroQOL (EQ)-5D questionnaire about generic health-related QOL. An EQ-5D index score utility ≤ 0.5 defined poor QOL and was used to generate a combined endpoint of death, transplant, VAD or poor QOL. Results: Of 150 patients enrolled, mean EF was 20%, 56% were INTERMACS profiles 6/7, 71% had ≥ 2 cardiac hospitalizations in the prior year. By 6 months, 18 patients died, 7 were transplanted, and 9 received a
VAD. Of the remaining cohort on medical therapy who answered EQ-5D at 6 months, an additional 9 (12%) were identified as having EQ-5D ≤ 0.5. Patients with EQ-5D ≤ 0.5 were more likely to express dissatisfaction with HF-related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire compared to EQ-5D > 0.5 (68 vs. 51%, p= 0.04). Baseline features were no different between patients with and without the combined endpoint. Adding poor QOL to death/transplant/VAD generated a 26% relative increase in the number of patients reaching an unfavorable 6 month endpoint (29% total). Conclusion: A combined endpoint integrating EQ-5D can be easily generated to describe unfavorable outcomes for ambulatory patients on medical therapy for HF. Since this endpoint tracks general rather than HF-related QOL, it could increase the statistical power and relevance of comparisons between VAD and medical therapy, but more importantly integrates the outcomes of most interest to patients who are considering VAD. 1( 043) Myocarditis Treated with VA-ECMO: A Single Centers Experience A. Burdorf , S. Varnado, J.L. Balk, T. Ryan, E. Raichlin, H. Vongooru, B. Lowes, R. Zolty, J. Um, H. Merritt-Genore, M. Moulton, A. Siddique. Nebraska Medicine, Omaha, NE. Purpose: Extracorporeal membrane oxygenation (ECMO) is increasingly used for cardiogenic shock from many causes. There is a high mortality in this population; however, picking the right patients for support may lead to improved outcomes. We sought to compare survival in patients with myocarditis with other diagnoses, and to identify variables that might be able to predict outcome. Methods: From our institutional ECMO database, we analyzed laboratory and outcomes data for 61 patients initiated on VA-ECMO to determine whether patients being treated for myocarditis had improved outcomes compared to non-myocarditis patients. We utilized t-test and wilkson-rank sum for parametric and non-parametric data. Results: We analyzed 61 patients supported exclusively with VA-ECMO between September 2006 and October 2015. From those 61 patients, 8 were treated for myocarditis. At 30 days, 5 were successfully weaned from support (63%), 1 was transplanted (12%) and 2 expired (25%). This contrasts with the non-myocarditis cohort, which had a 66% 30-day mortality rate (p= 0.05). The median duration of support was 8 [IQR 4.25; 18.5] days in the myocarditis cohort compared to 3 [IQR 2; 8] days in the overall cohort (p= 0.02). We collected 13 laboratory variables (CBC, sodium, BUN, creatinine, bicarbonate, AST, ALT, total bilirubin and lactic acid) obtained upon ECMO initiation. There were no significant differences found between the above parameters. Based upon this analysis, we were unable to detect laboratory variables that were associated with positive outcomes. Despite longer durations of support, it appears that patients with myocarditis have increased survival at 30 days when compared to patients supported on VA-ECMO for other indications. Conclusion: Patients treated with VA-ECMO for myocarditis have improved survival compared to other indications for VA-ECMO but a larger trial is needed to confirm this single-center data. Pre-implant laboratory parameters were not significantly different between myocarditis and non-myocarditis patients.