Depression Does Not Affect Outcomes in Patients with Left Ventricular Assist Devices

Depression Does Not Affect Outcomes in Patients with Left Ventricular Assist Devices

S218 The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014 Purpose: Continuous-flow left ventricular assist devices (LVAD) have ...

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S218

The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014

Purpose: Continuous-flow left ventricular assist devices (LVAD) have become the standard of care for patients with advanced heart failure as a bridge to heart transplant (HTx). Transplanting these patients is usually challenging and the influence of LVAD bridging on post-transplant outcomes remains controversial. Experienced centers have comparable post-transplant results with the LVAD bridging; however, the international registries continue to identify it as a risk factor for increased mortality after HTx. We evaluate the influence of the Organ Care System (OCS) as a method of graft preservation on the postoperative results and early survival in LVAD patients bridged to HTx. Methods: Retrospective study of all LVAD patients bridged to HTx at a single center from 07.2007 to 11.2013. Outcomes in the patients transplanted with the grafts preserved with OCS (n= 8) were compared with the ones preserved on ice (n= 14)-Standard of care (SOC). Results: During this period 135 patients were implanted with LVAD and 22 (16.3%) were bridged to HTx. There was no significant difference in donor age (OCS Vs SOC 38±12 Vs 33±10 yrs; p= 0.28) and recipient age (42±15 Vs 46±13 yrs; p= 0.48), in the donor characteristics (gender, cause of death, previous cardiac arrest, diabetes mellitus, inotropic support) or recipient baseline characteristics (gender, type of VAD, time on VAD support, driveline infection, pulmonary vascular resistance and renal function. 30 days survival was 100% vs. 78% (OCS vs. SOC). Conclusion: The OCS reduces the cold ischemic time and insult of prolonged cold storage. It allows for optimization of logistics and extended and meticulous preparation of the VAD and recipient. Despite the significant increase in out of body time we observed less right heart failure, better graft function and the recipients required significantly less blood products. Postoperative results are excellent, and use of the OCS in the transplantation of VAD patients has become the standard of care in our clinical practice.

Table 1. Relevant data

Cold ischemic time OCS run length Out of body time Mechanical circulatory support Inotropic support > 1wk Blood Loss 24h (ml) Blood products transfused 24h (units) Length inotropes-hours Length inhaled Nitric Oxide-hours Renal Replacement therapy ITU stay-days Hospital stay-days

OCS (n= 8)

SOC (n= 14)

P value

89.6 ± 16.9 (59 - 116) 287±130 (132 464) 378±128 (215 521) 12.5%

203.3 ± 30.4 (146-253)

0.001

N/A

N/A

203.3 ± 30.4 (146-253)

0.002

64.3%

0.031

12.5% 725±176 13.1±7.4

64.3% 2175±1716 29.1±11.4

0.031 0.047 0.002

104±105 (30-336) 186±89 (92-360) 25.7±19.8 47.5±30.6

0.092 0.088

37.5%

0.081

78.6%

9.38±14.08 (2-44) 29.6 ± 22.9 (2-74) 27.6±9.9 (16-44) 52.2 ± 36.5 (2-121)

0.035 0.033

Methods: A review of 102 consecutive patients receiving a 3rd generation LVAD between January 2009 and September 2013. Results: Consecutive patients (N: 102; female 13; mean age 47±13) with 3rd generation LVADs. Intermacs: 1 N= 6, 2 N= 37, 3 N= 25 and 4 N= 34. Median follow up was 620±462 days with a median duration of support of 445±422 days. All cause mortality was 26% and 37% at one and two years respectively and survival on device was 75% and 68% for the same time points. Older age (> 50) was the most significant factor related to reduced survival (P< 0.05), and this was predominantly related to death within the first 90 days. Intermacs groups 1+2 had worse outcomes at 90 days compared to Intermacs 3+4 (P< 0.05). In our cohort only 14/102 patients were transplanted at a median of 334±347 days, and only 3 were transplanted in the first 6 months. Conclusion: In this single centre cohort of BTT 3rd generation VAD implants with a low rate of transplantation, we demonstrate excellent survival with up to 4.5 years follow up. This extended bridge to transplantation practice argues strongly in favour of adoption of destination therapy in the UK. 5( 87) Two-year Survival After Continuous-flow Left Ventricular Assist Device Versus Heart Transplantation: An Italian Single Centre Perspective E. Ammirati , F. Oliva, T. Colombo, C.F. Russo, M. Cipriani, A. Garascia, L. Botta, A. Verde, A. Cannata, R. Paino, L. Martinelli, M. Frigerio.  Cardiovascular and Thoracic, AO Ospedale Niguarda Ca’ Granda, Milan, Italy. Purpose: Donor shortage and their ageing, in particular in Europe, limit the availability and the probability of success of heart transplantation (HTx). Meanwhile, the outcome after left ventricular assist device (LVAD) implantation is improving, but data on direct comparison are few. The aim of this study is to compare 2-year outcome in prospective patients treated with HTx or LVAD in a single centre. Methods: We evaluated 213 consecutive patients with advanced heart failure (HF) treated with continuous-flow LVAD (n=  49) or HTx (n= 164) from 1/2006 to 2/2012 and follow up until 11/2013. Two-year outcome were compared in the overall population and in subgroups (LVAD and HTx matched groups; LVAD as bridge-to-transplant (BTT) indication vs. HTx. Results: LVAD patients had a worse hemodynamic and clinical preoperative profile in comparison with HTx patients. After a median follow up of 24 month (interquartile 15 to 24 months), with 180 (85%) patients reaching 2-year follow up, 48 deaths occurred: 14 among LVAD patients (0.24 per patient-year) vs. 34 among HTx patients (0.13 per patient-year). Kaplan Meier estimated 2-year survival was 71.4% in LVAD vs. 79.3% in HTx patients (HR for death 1.56; 95%CI 0.84-2.92; p= 0.16 for LVAD vs. HTx). Two-year survival was not significantly different also when comparing matched groups of LVAD (71.8%) and HTx (76.9%) patients (HR=  1.35; 95%CI 0.56-3.28, p= 0.50). Patients undergoing LVAD implant as BTT (n= 22, 45%) showed non-significantly higher 2-year survival (90.9%) in comparison with HTx patients (79.3%; HR 0.43, 95%CI 0.10-1.80, p= 0.25), despite a rate of HTx as low as 32% (n= 7) in the LVAD group with BBT indication. Conclusion: in the short to mid term, LVAD is becoming a competitive treatment in comparison with HTx. The potential for long term LVAD treatment and donor hearts allocation priorities represent the contemporary challenge.

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Extended Bridge To Transplant: 4 Years Outcomes With 3rd Generation LVADs in an Era of Restricted Transplantation T.A. Butt , F. Ozalp, N. Wrightson, N. Robinson Smith, A. Woods, G. Parry, M. Griselli, A. Hasan, S. Schueler, G. MacGowan.  Institute of Cardiopulmonary transplantation, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.

Depression Does Not Affect Outcomes in Patients with Left Ventricular Assist Devices D.S. Raymer , M.E. Nassif, J.M. Vader, E. Novak, G.A. Ewald, S.J. LaRue.  Cardiovascular Division, Barnes-Jewish Hospital, St. Louis, MO.

Purpose: Mechanical circulatory support is well established as a bridge to transplant (BTT) for patients in end-stage heart failure. In recent clinical trials BTT rates are approximately 30% at 6 months. In the UK however there is a significant discrepancy between the number of patients on the waiting list and availability of donors.

Purpose: Depression is prevalent in patients with heart failure (HF) and is associated with an increased mortality and rehospitalization rate. The prevalence and clinical impact of depression in patients with continuous-flow left ventricular assist devices (LVADs) has not been established. Methods: We performed a retrospective cohort study of patients who survived their index admission for continuous-flow LVAD implantation. We identified

Abstracts S219 254 patients implanted with a Heart Mate II (n =  227) or Heartware HVAD (n =  27) LVAD between 6/2005 and 4/2013. Patients with a pre-implant diagnosis of depression or on a selective serotonin reuptake inhibitor (SSRI) without other indication were compared to those without. The primary outcome was time to rehospitalization. Secondary outcomes included number of rehospitalizations per patient-year, time to first infection, gastrointestinal bleeds (GIB) per patient-year, and death. Results: The majority of patients were implanted with Heart Mate II LVADs and with a median INTERMACS profile of 2 at the time of LVAD implantation. The depression group had significantly more females (33% vs. 17%, p =  0.013), ischemic cardiomyopathy (59% vs. 38%, p =  0.009), and a history of smoking (68% vs. 52%, p =  0.047). There were no significant differences between cohorts with respect to age, race, history of atrial fibrillation or GI bleeding, diabetes, BMI, or implant strategy. During a follow-up period of 345.2 patient-years there were 718 rehospitalizations. There was no difference in time to first rehospitalization (p =  0.71). There were also no differences in time to first infection (p =  0.3), time to death (p =  0.78), or time to first infection or death (p =  0.31). There were no differences in GIB events (p =  0.25) or rehospitalizations (p =  0.39) per patient-year. Conclusion: In this sample of patients with continuous-flow LVADs, a history of or treatment for depression prior to implantation was not associated with an increased incidence of rehospitalization, infection, GIB, or death.



5( 90) Successful LVAD Therapy in Patients Ineligible for Heart Transplantation Due to Psychosocial Considerations N. Rajagopalan , T.A. Tribble, D.R. Dennis, R. Yanagida, C.W. Hoopes.   University of Kentucky, Lexington, KY.

5( 89) Psychosocial Assessment of Candidates for Transplantation Score and Readmissions in HeartMate II Bridge to Transplant Left Ventricular Assist Device Patients S. Schettle , A. Luckhardt, J. Schirger, B. Boilson.  Cardiovascular Surgery, Mayo Clinic Rochester, Rochester, MN. Purpose: The psychosocial assessment of candidates for transplantation (PACT) score is well validated in transplant populations but is not well studied in bridge to transplant (BTT) LVAD (left ventricular assist device) recipients. We sought to characterize PACT score impact in BTT patients receiving a HeartMate II (HM2) device. Methods: All BTT patients that underwent HM2 LVAD implant from January 2008 to July 2013 were retrospectively analyzed. PACT scores were completed in 51 of the 71 total patients prior to LVAD implant. Transplantation was considered an endpoint. Patients that died during initial LVAD hospitalization were excluded. We reviewed readmissions after initial LVAD hospitalization in the 48 remaining patients with PACT scores. Results: We identified 48 patients with PACT scores ranging from 1 to 4. Due to small sample size and potential skewing of outliers, we used mode to determine readmissions for each PACT score. A mode of 2, 1, 0, and 0 readmissions was associated with a PACT of 1, 2-2.5, 3, and 4, respectively (Figure 1). 0% of patients with a PACT of 1, 43% with a PACT of 2-2.5, 63% with a PACT of 3, and 67% with a PACT of 4 were transplanted (Figure 2). Statistical significance was not achieved due to small sample size. Conclusion: Higher PACT scores correlated with fewer readmissions and greater percentage of patients undergoing heart transplantation in HM2 BTT LVAD patients. No such score exists for destination therapy (DT) LVAD patients. Implementing PACT scores for DT LVAD recipients may hold potential to aid in predicting readmissions.

Purpose: Potential heart transplant candidates undergo extensive psychosocial evaluation due to the strict compliance that is required posttransplantation. Implantation of a left ventricular assist device (LVAD) also requires considerable compliance to attain a good outcome. Our purpose was to determine the outcome of LVAD therapy in heart failure patients who were ineligible for transplantation due to psychosocial considerations. Methods: We retrospectively identified 25 patients who underwent placement of a HeartMate II LVAD after being denied listing for heart transplantation primarily due to psychosocial considerations. The primary psychosocial issue was: recent history of documented non-compliance in 9 patients (36%), continued tobacco abuse in 8 patients (32%), recent substance abuse in 5 patients (20%), and lack of adequate social support in 3 patients (12%). We examined all-cause mortality and incidence of major complications at 1 year post-implantation. Results: Clinical characteristics were as follows: mean age 48 ± 10 years (range 20-63 years), 16 males (64%), 15 patients (60%) with ischemic etiology for heart failure, and previous sternotomy in 8 patients (32%). The majority of patients underwent LVAD implantation at INTERMACS profile 2 or 3 (76%). One-year survival was 88%. Two patients died from cerebrovascular accident and the third was from out of hospital arrest due to unknown cause. Eight patients (32%) were listed for heart transplantation at 1 year post-implant. Major complications in survivors included: 1 patient with LVAD thrombosis requiring pump exchange; 1 patient with device failure related to noncompliance requiring device explant; and 2 patients with recurrent driveline infections requiring hospitalization for intravenous antibiotics. Conclusion: LVAD therapy is a reasonable alternative for advanced heart failure patients who are not candidates for heart transplantation due to psychosocial considerations. Some patients can demonstrate improvement in psychosocial behaviors on LVAD support leading to eventual listing for heart transplantation. While short-term mortality was excellent, further follow-up is needed to assure long-term survival.