Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device

Abstracts S231 cardiovascular collapse as a bridge for either end-organ recovery and subsequent definitive therapy or recovery. We hypothesize that ECMO is an effective bridge strategy for subsequent transplant, ventricular assist device (VAD), or recovery. Methods: A retrospective review of the ECMO registry from 2008 to 2014 at a single institution was conducted (n= 265). Patients who had ECMO for post-cardiotomy failure and primary pulmonary pathology were excluded. Patient demographics, comorbidities, and peri-operative outcomes were evaluated. Primary outcome was mortality with secondary outcomes of length of stay and complications. Results: Of the initial cohort, 66 patients expired (54%), 22 patients recovered (18%), and 33 patients (27%) were bridged to either OHT or VAD. There was no significant difference in demographics or comorbidities amongst the cohorts. The main etiology for cardiogenic shock was ischemic. A statistically higher percentage of patients in Recovery had arrhythmias as the primary etiology of heart failure (36.4 % vs. 9.1%, p= 0.01). Within 1 hour of ECMO cannulation, 21.2% ECMO-bridge and 36.4% Recovery cohorts received CPR. All cohorts had similar ICU and hospital lengths of stay. 30 day survival was 72.7% and 90.9% for ECMO-bridge and Recovery groups (p= 0.41). ECMO-VAD had lower 1 year survival of 43.5% compared to ECMO-OHT (70.0%) and Recovery (81.8%) (p= 0.08). Conclusion: As a salvage strategy in high risk patients, ECMO provides a viable rescue means for cardiac stabilization and resuscitation to definitive treatment. Promising results can be obtained with bridging to subsequent transplant, VAD, or recovery following an initial period of support with ECMO. A bridge to recovery strategy can have minimal co-morbidities and excellent long term survival.

ECMO-Bridge (OHT and ECMO-OHT VAD) (n= 33) (n= 10)

ECMO-VAD (n= 23)

Recovery (n= 22)

p-value

Age, y 50.3 + 14.9 Male, n (%) 21 (63.6) BMI, kg/m2 27.1 + 4.8 Heart failure: 19 (57.6) Ischemic 5 (15.2) Heart failure: Non-ischemic cardiomyopathy Heart failure: 3 (9.1) Arrhythmia 1.24 + 0.66 Baseline Serum Creatinine, mg/dL 1.13 + 0.56 Baseline Total Serum Bilirubin, mg/dL 6 (18.2) CPR at time of ECMO cannulation, n (%) 7 (21.1) CPR within 1 hour of ECMO cannulation, n (%) Post-op Stroke 6 (18.2) 13 (39.4) Post-op Acute Kidney Injury Requiring Dialysis 7 (21.1) Post-op Liver Failure (Defined by Total Bilirubin > 2.0) Post-op Vascular 7 (21.9) Complication 13 (10) ICU time initial admission (days) 17 (21) Total ICU time for hospital course (days) Length of stay 36 (12) (days)

47.1 + 11.23 5 (50) 23.7 + 5.3 6 (60.0)

51.7 + 16.4 16 (69.6) 28.8 + 3.6 13 (56.5)

52.3 + 19.4 17 (77.3) 27.8 + 4.8 9 (40.9)

0.28 0.45 0.23 0.13

1 (10.0)

4 (17.4)

1 (4.6)

0.08

2 (20.0)

1 (4.4)

8 (36.4)

0.01

1.01 + 0.24

1.39 + 0.81

1.85 + 1.10

0.49

1.2 + 0.73

1.1 + 0.47

1.85 + 1.5

0.63

2 (20.0)

4 (17.4)

5 (22.7)

0.85

2 (20.0)

5 (21.7)

8 (36.4)

0.66

3 (30.0) 4 (40.0)

3 (13.0) 9 (39.1)

3 (13.6) 2 (9.1)

0.24 0.01

2 (20.0)

5 (21.7)

1 (4.6)

0.24

1 (10.0)

6 (26.1)

5 (22.7)

0.85

7 (8)

11 (18)

14 (24)

0.40

16 (19)

36 (13)

29 (25)

0.55

40 (24)

36 (13)

29 (25)

0.60

30-day Survival (%) 1-year Survival (%)

72.7

70.0

73.9

90.9

0.41

57.1

66.7

52.6

86.7

0.08

6( 21) Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device S.A. Hall , B. Lima, P. Kale, J.J. Kuiper, S. Carey, A.E. Shafii, T. Chamogeorgakis, G.V. Gonzalez-Stawinski.  Baylor University Medical Center, Dallas, TX. Purpose: Many Stage D heart failure patients require temporizing mechanical circulatory support to assess the best long-term treatment strategy. This study examined use of the Impella 5.0/LD as a bridge to transplant or durable LVAD support. Methods: Patients (N =  62) in cardiogenic shock or with decompensated heart failure (inotrope-dependent, RV failure, end-organ dysfunction) were supported between March 2009 and April 2014 with an Impella 5.0/LD device at a single institution. Prospectively, peri-procedural and intermediateterm outcomes were analyzed using a clinical registry database. Results: A total of 27 patients (44%) were supported with the Impella 2.5 (n = 26) or CP (n = 1) and excluded from the analysis. Baseline demographics (N =  35) included a mean age of 55 years, 66% male sex, 71% renal insufficiency (serum creatinine 2.1 mg/dL), 44% mechanical ventilation, 16% LVEF, and 48% RV dysfunction. Impella 5.0/LD support yielded significant improvements in systolic, diastolic, and mean arterial blood pressure from 89 to 101, 60 to 68, and 70 to 81, respectively (P < 0.05). Cardiac index was significantly improved from 1.7 to 2.5 (P = 0.03); pulmonary artery diastolic pressure decreased from 34 to 20 (P = 0.001). Procedure-related complication rate (limb ischemia, bleeding requiring surgery, hematoma) was 0%. Patients were eventually bridged to recovery (n = 4, 11%), heart transplant (n =  15, 43%), or durable LVAD implant (n = 16, 46%). Survival rates to discharge for recovery, transplant, and LVAD groups were 25%, 60%, and 56%, respectively. Conclusion: Temporary Impella 5.0/LD support is effective for hemodynamic stabilization and multidisciplinary reassessment of critically ill heart failure patients. Many such patients can be successfully bridged to recovery, cardiac transplant, or durable LVAD support. 6( 22) Comparison of GI Bleeding Rates Between Axial Flow and Centrifugal Flow LVADs F.H. Sheikh ,1 D.T. Majure,1 J. Salcedo,2 M. Hofmeyer,1 G. Ruiz,1 M.E. Rodrigo,1 T. Elliott,1 E.J. Molina,1 S.W. Boyce,1 S.S. Najjar.1   1MedStar Heart Institute, Washington, DC; 2MedStar Washington Hospital Center, Washington, DC. Purpose: Gastrointestinal bleeding (GIB) is a common complication of continuous flow left ventricular assist devices (LVADs). Due to differences in the intensity of anticoagulation/the usage of antiplatelets (and pump design) between the HVAD and HeartMate II (HMII), it is possible that rates of GIB may differ between the 2 devices. We sought to compare the rates of GIB between HMII and HVAD at our institution. Methods: Single center retrospective review of all patients implanted with a LVAD between January, 2011 and October, 2014. GIB was defined as melena, hematochezia, hematemesis, or anemia requiring either a transfusion or an endoscopy/colonoscopy. Results: 66 received a HMII and 104 patients received a HVAD. Total followup was 85 patient-years for HMII and 102 patient-years for HVAD. The mean follow up for the HMII was 1.0 years and 1.3 years for the HVAD. The mean age was 59±11 for HMII and 58 ± 11 for HVAD, p= 0.7. The LVAD recipients were mostly men (88% in HMII group, 61% in HVAD group, p= 0.06) and mostly African-American (71% HMII, 72% HVAD, p= 0.5). Of patients who experienced a GI hemorrhage, the median time to first bleed was 8.2±3.5 months for the HMII and 3.5±0.98 months for the HVAD (p= 0.07). 26% of HMII and 18% of HVAD patients experienced at least one GIB (p= 0.6). 9% of HMII and 10% of HVAD patients experienced more than one GIB. At the time of the GIB, 83% of patients with HMII were on warfarin and 43% were on ASA; 79% of patients with HVAD were on warfarin and 77% were on ASA. Mean INR at the time of GIB did not differ between the 2 groups: 2.57 ±2.3 for HMII and 2.56 ± 1.9 for HVAD, p= 0.9. There was no significant difference in the cumulative incidence of GIB (0.24 eppy for HMII vs. 0.22 eppy for HVAD, p= 0.7, see Figure). Conclusion: GIB is a frequent complication in patients with LVADs. Despite differences in anticoagulation and antiplatelet therapy, there was no difference in the rate of GIB between HVAD and HMII recipients. Future research