How do Readmissions Impact Survival among Patients with Continuous-Flow Left Ventricular Assist Devices? Findings from INTERMACS

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1 How do Readmissions Impact Survival among Patients with Continuous-Flow Left Ventricular Assist Devices? Findings from INTERMACS Rey P. Vivo, MD 1 ; Selim R. Krim, MD 2 ; Jerry D. Estep, MD 3 ; Wissam I. Khalife, MD 4 ; Gregg C. Fonarow, MD 1 ; Robert L. Kormos, MD 5 ; Susan L. Myers 6 ; Mario C. Deng, MD 1 1 UCLA Medical Center, Los Angeles, CA, 2 John Ochsner Heart and Vascular Institute, New Orleans, LA, 3 Methodist DeBakey Heart and Vascular Center, Houston, TX, 4 University of Texas Medical Branch, Galveston, TX, 5 University of Pittsburgh Medical Center, Pittsburgh, PA, 6 University of Alabama at Birmingham, Birmingham, AL 1

2 Disclosures Author Disclosure Information: R.P. Vivo: None; S.R. Krim: None; J.D. Estep: None; W.I. Khalife: None; G.C. Fonarow: None; R.L. Kormos: None; S.L. Myers: Current/Ongoing - Payment Made to My Institution; Grant/Research Support; HeartWare, Inc., Thoratec Corp.; M.C. Deng: None INTERMACS Disclosure Information: "This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN C." 2

3 Background Based on INTERMACS data, adult patients with CF-LVAD have 59%, 44% and 28% freedom from readmissions at 3, 6 and 12 months, respectively, post-implant discharge. 1 The association between readmissions and survival in this population is unclear. While several pre-implant variables have been shown to predict the risk for death, post-implant predictors for survival are not well elucidated. 2 Rationale: Defining the prognostic implications of 90-day readmissions for 1-year survival in LVAD patients may be useful for risk stratification and for targeted interventions to improve long-term survival. 1. Kormos, RL, et al. J Heart Lung Transplant. 2011;30:S9. (abst) 2. Kirklin JK, et al. J Heart Lung Transplant. 2012;31:

4 Hypothesis Given the high rates of readmissions in LVAD patients and the direct relationship between frequency of hospitalizations and death in patients with advanced HF without mechanical support, we hypothesize that higher readmission rates will likely portend poorer survival among patients supported with CF-LVAD. 4

5 Specific Aims Examine the association between 90-day readmission rates (post-index discharge) and adjusted 1-year survival among patients supported by CF-LVAD as either bridge or destination strategy. Evaluate the impact of various reasons for rehospitalizations on survival in this patient population. 5

6 Study Population All Primary Pts implanted As of 3/31/ Pediatric Patients: (patients < 19 yrs of age at time of implant) N=78 Adults: N=8531 Pulsatile Flow: N=1127 Continuous Flow: N=7404 BiVAD: n=309 TAH: n=190 LVAD: n=628 BiVAD: n=192 LVAD: n=7212 6

7 Study Population Inclusion Criteria (Institutions: 132) Adult ( 19yrs) Primary implant Continuous Flow LVAD/Bi-VAD Implant dates: 04/21/ /31/2013 Follow-up through 03/31/2013 Discharged alive with original device in place Initially discharged to: n % (n=7404) N=7404 Home Residential Setting % Nursing Home/Assisted Care % Hospice 3 0.1% Another hospital % Rehabilitation Facility % Unknown % Dead/Txpl/Recovery index hospitalization* 762* 10.3% No Discharge Date (=not discharged) % Total % N=6492 LVAD: n=6385 Bi-VAD: n=107 * These patients had either a death, transplantation, exchange or recovered in the initial hospitalization or discharge was after the end of follow-up time point (3/31/2013) 7

8 Study Population Patients discharged alive with device in place N=6492 Cohort of Interest Patients alive with original device in place at time of index discharge + 90 days N=5379 Start Start Implant Discharge Discharge + 90 days 8

9 Time Zero Patients alive with original device in place at time of index discharge + 90 days, N=5379 How do rehospitalizations in this time period affect survival here? Hospital Discharge 90 days post Discharge Months post implant 9

10 Rehospitalization Discharged alive Alive at 90 days within 90 days w/ original device post-discharge (57.2%) 3182 (59.2%) (26.4%) 1325 (24.6%) (11.1%) 575 (10.7%) (3.9%) 209 (3.9%) 4 70 (1.1%) 67 (1.2%) 5 14 (0.2%) 11 (0.2%) 6 or more 10 (0.1%) 10 (0.2%) Total N Note: Rehospitalizations are for follow-up while original device is in place 10

11 Patients alive with original device in place at time of index discharge + 90 days, N=5379 P(overall) <.0001 P(rehosp 1 v rehosp 2 v rehosp 3) =.001 Group n events No Rehospitalization in 90 days (12%) 1 Rehospitalization in 90 days (17%) 2 Rehospitalizations in 90 days (19%) 3 Rehospitalizations in 90 day (26%) Event: Death with original device in place and censored at transplant or recovery Months after Index Discharge + 90 days 11

12 Patients alive with original device in place at time of index discharge + 90 days, N=5379 Device Strategy at time of implant n % Bridge to transplant, listed % Bridge to Candidacy % Destination Therapy % Rescue Therapy % Bridge to Recovery % Other % Total % 12

13 Patients alive with original device in place at time of index discharge + 90 days, N=5379 Device Strategy at time of implant: Bridge to Transplant-Listed P(overall) =.004 P(rehosp 1 v rehosp 2 v rehosp 3) =.96 Group n events No Rehospitalization in 90 days (10%) 1 Rehospitalization in 90 days (14%) 2 Rehospitalizations in 90 days (16%) 3 Rehospitalizations in 90 day 49 8 (16%) Event: Death with original device in place and censored at transplant or recovery Months after Index Discharge + 90 days 13

14 Patients alive with original device in place at time of index discharge + 90 days, N=5379 Device Strategy at time of implant: Bridge to Candidacy P(overall) <.0001 P(rehosp 1 v rehosp 2 v rehosp 3) =.002 Group n events No Rehospitalization in 90 days (11%) 1 Rehospitalization in 90 days (15%) 2 Rehospitalizations in 90 days (15%) 3 Rehospitalizations in 90 day (31%) Event: Death with original device in place and censored at transplant or recovery Months after Index Discharge + 90 days 14

15 Patients alive with original device in place at time of index discharge + 90 days, N=5379 Device Strategy at time of implant: Destination Therapy P(overall) =.0002 P(rehosp 1 v rehosp 2 v rehosp 3) =.10 Group n events No Rehospitalization in 90 days (16%) 1 Rehospitalization in 90 days (20%) 2 Rehospitalizations in 90 days (23%) 3 Rehospitalizations in 90 day (26%) Event: Death with original device in place and censored at transplant or recovery Months after Index Discharge + 90 days 15

16 INTERMACS Levels 1-3 at time of implant INTERMACS Levels 4-7 at time of implant P(overall) <.0001 P(rehosp 1 v rehosp 2 v rehosp 3) =.009 P(overall) =.0005 P(rehosp 1 v rehosp 2 v rehosp 3) =.09 Group n events No Rehospitalization in 90 days Rehospitalization in 90 days Rehospitalizations in 90 days Rehospitalizations in 90 day Group n events No Rehospitalization in 90 days Rehospitalization in 90 days Rehospitalizations in 90 days Rehospitalizations in 90 day Months after Index Discharge + 90 days Months after Index Discharge + 90 days Event: Death with original device in place and censored at transplant or recovery 16

17 Multivariable Analysis based on Reason for Readmission Unadjusted Adjusted* Hazard ratio p-value Hazard ratio p-value Reasons for Rehospitalizations during 90 days: Infection Rehosp 2.77 < <.0001 RV Failure Rehosp 2.68 < Pulmonary Disorder Rehosp 2.59 < Neurological Rehosp Cardiac Arrhythmia Rehosp Bleeding Rehosp Planned Procedure Rehosp Total # Rehosp 1.41 < <.0001 * Effect of rehospitalizations are adjusted for significant pre-implant risk factors (age, creatinine, INR, RA pressure, ascites, history of CABG, INTERMACS Level) 17

18 Infection* Rehospitalizations RV Failure* Rehospitalizations P(overall) <.0001 P(overall) < days post index discharge n events No Rehospitalization Rehospitalization for infection 449* 121 Rehospitalizations for other reasons days post index discharge n events No Rehospitalization Rehospitalization for RV Failure 158* 44 Rehospitalizations for other reasons Months after Index Discharge + 90 days Months after Index Discharge + 90 days * 509 Infection readmissions in 449 patients *184 RV Failure readmissions in 158 patients Event: Death with original device in place and censored at transplant or recovery 18

19 Pulmonary* Rehospitalizations Neurologic* Rehospitalizations P(overall) <.0001 P(overall) < days post index discharge n events No Rehospitalization Rehospitalization for Pulmonary d/o 120* 42 Rehospitalizations for other reasons days post index discharge n events No Rehospitalization Rehospitalization for Neuro Dys 204* 51 Rehospitalizations for other reasons Months after Index Discharge + 90 days Months after Index Discharge + 90 days *133 Pulmonary readmissions in 120 patients * 221 Neurologic readmissions in 204 patients Event: Death with original device in place and censored at transplant or recovery 19

20 Conclusions The number of 90-day rehospitalizations is strongly associated with increasing 1-year mortality among CF- LVAD patients in the INTERMACS registry. Readmissions due to infections and RV failure were associated with the worst adjusted 1-year survival. Patients readmitted within 90 days may benefit from more intensive follow-up and monitoring. Measures to reduce rehospitalizations may help improve survival in this patient population. 20

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