Renal Failure Is Not a Contraindication to Left Ventricular Assist Device Implantation

Renal Failure Is Not a Contraindication to Left Ventricular Assist Device Implantation

Abstracts S327 Surgery, Johns Hopkins School of Medicine, Baltimore, MD; 5Cardiology, Johns Hopkins School of Medicine, Baltimore, MD. Purpose: Left v...

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Abstracts S327 Surgery, Johns Hopkins School of Medicine, Baltimore, MD; 5Cardiology, Johns Hopkins School of Medicine, Baltimore, MD. Purpose: Left ventricular assist devices (LVAD) are increasingly used, especially as destination therapy in elderly. The aim of this study was to evaluate the effect of age on renal function and mortality in the first year after implantation. Methods: A retrospective multicenter cohort study was conducted, evaluating all LVAD patients implanted in the two participating centers (age ≥ 18 years and minimal survival > 48 hrs). Patients were stratified according the age groups < 45, 45-54, 55-54, and ≥ 65 years old. Results: Overall, 241 patients were included (mean age 52.4 ± 12.9 years, 76% males, 33% destination therapy). The mean eGFR at one year was 85, 72, 69, and 49 mL/min per 1.73 m2 in the age groups < 45, 45-54, 55-54, and ≥ 65 (p <  0.001) respectively. Ages 55-65 (p= 0.04) and ages ≥ 65 (p< 0.001) were independent predictors of worsening renal function (eGFR) at one year. The one-year survival post-implantation was 79%,84%, 68%, and 54% for those in the age group < 45, 45-54, 55-64 and ≥ 65 (Log-rank p= 0.003). Age ≥ 65 (p= 0.02) was an independent predictor of one-year mortality. When stratified by age < 60 and ≥ 60 years and sub-classified in to eGFR classes, the one-year survival was 86%, 73%, 67%, 69%, 56% and 43% (Log-rank p= 0.035, figure 1), respectively. Conclusion: Older age adversely affects renal function and survival one-year post-implantation. Older age combined with reduced renal function had a cumulative adverse effect on survival and is important to consider when selecting patients for LVAD implantation.

1( 004) Cardiac Rotational Mechanics as a Predictor of Favorable Functional Response Induced by Cardiac Assist Devices in Advanced Heart Failure M.J. Bonios ,1 I. Taleb,1 R. Larsen,1 O. Wever-Pinzon,1 A.G. Kfoury,2 R. Alharethi,2 J. Nativi-Nicolau,1 W. Caine,2 S.H. McKellar,1 A. Koliopoulou,1 C.H. Selzman,1 S.G. Drakos.1  1University of Utah, Salt Lake City, UT; 2Intermountain Medical Center, Salt Lake City, UT. Purpose: Impaired qualitative and quantitative left ventricular rotational mechanics strongly predict cardiac remodeling progression and prognosis after myocardial infarction. Given the absence of established pre-left ventricular assist devices (pre-LVAD) predictors of favorable cardiac functional response we investigated whether cardiac rotational mechanics can predict cardiac recovery in chronic advanced cardiomyopathy patients (CMP). Methods: 63 advanced chronic and dilated CMP undergoing implantation of LVAD were prospectively investigated (acute heart failure patients were prospectively excluded), using speckle tracking echocardiography. We evaluated left ventricular (LV) rotational mechanics [apical and basal LV twist, LV torsion] and deformational mechanics [circumferential (CS) and longitudinal strain (LS)] before LVAD implantation. Cardiac recovery post-LVAD implantation was defined as (i) final resulting LV ejection fraction (LVEF) ≥  40%, (ii) relative LVEF increase ≥  50%, (iii) relative LVESV decrease ≥  50% (all 3 required). Results: 12 patients fulfilled the criteria for cardiac recovery (Rec Group). The pre-LVAD implantation findings for the Rec and Non-Rec Groups are summarized in the table. The Rec Group had significantly less impaired pre-LVAD peak LV Torsion compared to the Non-Rec Group. By ROC curve analysis, pre-LVAD peak LV torsion of 0.35 o/cm had a 91% sensitivity and a 72% specificity in predicting cardiac recovery. Peak LV torsion before LVAD

implantation was found to be an independent predictor of cardiac recovery following LVAD implantation [OR 0.01 (0.01-0.66), p= 0.014. Conclusion: Left ventricular quantitative and qualitative (direction of rotation) rotational mechanics appear to be useful in selecting patients prone to cardiac recovery during LVAD mechanical unloading. Future studies should define the utility of these markers in predicting durable cardiac recovery following the explantation of the LVAD.

1( 005) Renal Failure Is Not a Contraindication to Left Ventricular Assist Device Implantation A. Kilic , C.W. Chen, A.C. Gaffey, J.W. Wald, M.A. Acker, P. Atluri.  University of Pennsylvania, Philadelphia, PA. Purpose: Selection criteria for durable left ventricular assist device (LVAD) implantation remain unclear. Renal function remains one of the cornerstones for selection of patients for LVAD therapy. The data on outcomes with compromised renal function with LVADs remain unclear. The purpose of this study was to review our experience with LVAD implantation in patients with renal failure. Methods: Patients undergoing LVAD implantation as destination therapy (DT) or bridge-to-transplant (BTT) at a single institution between 2006-2015 were included. Primary stratification was by pre-implant glomerular filtration rate (GFR): > 60 ml/min versus < 60 ml/min or dialysis-dependence. The primary outcome was post-LVAD overall survival. Results: 238 patients underwent LVAD implantation during the study period as DT (60%; n= 142) or BTT (40%; n= 96). Reduced GFR was present in 56% (n= 132), with 8% (n= 18) being dialysis-dependent. Normal versus reduced GFR cohorts were well matched. The average follow-up was 13.5±17.0 months and was similar between groups. Kaplan-Meier survival at 1, 3, 6, and 12 months post-LVAD was similar between the normal and reduced GFR cohorts for both DT and BTT (Figure). Risk-adjusted analysis confirmed these findings. Rates of major complications were similar except for rates of sepsis which were higher (12% versus 4%; p= 0.03) and rates of arrhythmia which were lower in the reduced GFR cohort (12% versus 26%; p= 0.02). Rates of transplantation in the BTT cohort were comparable between groups (61% normal versus 53% reduced; p= 0.43). Recovery of renal function to a GFR > 60 ml/min occurred in 43% (n= 17) and 57% (n= 42) of reduced GFR patients in the BTT and DT cohorts, respectively, by 1-year post-implant. Conclusion: Well-selected patients with pre-existing renal failure can undergo LVAD implantation with acceptable outcomes, with approximately half recovering normal renal function within the first year. Renal failure alone should not serve as a contraindication to LVAD therapy.

S328

The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017

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implant between July 1, 2012 and December 31, 2013 (N =  237) without case review or prior authorization. The ‘prior authorization group’ was comprised of patients whose cases were reviewed through the prior authorization process between January 1, 2014 and June 30, 2015 (N =  318); of these, 194 patients were approved to receive a VAD implant following case review and 124 patients either withdrew their cases because they did not meet prior authorization criteria (n =  119) or were denied a VAD implant following case review (n =  5). Outcomes were tested using two sets of comparison groups:

ECMO-Bridge to LVAD Therapy Is a Safe and Effective Strategy for Critically Ill Patients J.J. Han ,1 C. Chen,1 J. Chung,1 A.C. Gaffey,1 A. Sotolongo,1 C.M. Justice,1 J.E. Rame,2 C. Bermudez,1 M.A. Acker,1 P. Atluri.1  1Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA; 2Cardiology, Hospital of the University of Pennsylvania, Philadelphia, PA. Purpose: Extra-corporeal membrane oxygenation (ECMO) as a bridge to left ventricular assist device (LVAD) implantation has been adopted as a strategy to improve end-organ function and optimize outcomes, though the practice remains controversial. Methods: Retrospective review of a high-volume center was performed with selection of patients who received LVADs from May 2008 to September 2016. Subjects were divided into two groups- ECMO-bridge patients and non-ECMO-bridge, INTERMACS class 1 patients. Patient demographics, adverse events, and survival at immediate- and 1-year-post-op time points were compared. Results: In total, 235 patients received a HeartMate II or HVAD during the study period. There were 18 ECMO-bridge and 17 non-ECMO-bridge patients with an INTERMACS class of 1. Age, gender and bridge-to-transplant proportions were similar between groups. The ECMO-bridge group had lower hemoglobin (7.9±1.1 vs 10.2±2.2, p< 0.01), platelet (101[70] vs 176[115], p< 0.05) and pre-albumin levels (10.6±4.3 vs 17.3±7.7, p< 0.01). Nearly half (n= 8, 44%) of the ECMO-bridge patients required pRBC transfusions prior to VAD and were more likely to be on an epinephrine drip (78% vs 12%, p< 0.01). However, the ECMO-bridge did improve hemodynamic profiles by the time of VAD implant resulting in lower CVP (7.7±2.5 vs 10.4±4.8 p< 0.01) and mPAP (18±9 vs 32±8 p< 0.01). It also allowed for restoration of end-organ function as noted by comparable creatinine (1[1.2] vs 1.4[0.6]) and total bilirubin levels (1.6±1 vs 1.5±1.7) between the two groups. Difference in rates of adverse events did not reach statistical significance. Survival at early post-op and at 1 year (77% vs 88% p 0.6) were similar, and comparable to the general VAD population (figure). Conclusion: This study demonstrates that a temporary ECMO-bridge is safe and an important component of a multi-faceted strategy to stabilize critically ill patients prior to LVAD implantation. Optimizing patient selection may be critical to improve prognosis, and should be further explored.

1( 007) The Impact of a VAD Prior Authorization Program on Patient Outcomes L.L. Ten Eyck ,1 W.M. Bannister,1 E. Liu,1 A. Bonagura,2 D. Irwin,2 M. Chen.2  1Optum Consumer Solutions Group Healthcare Analytics, Optum, Minneapolis, MN; 2Complex Medical Conditions, Optum, Minneapolis, MN. Purpose: This study measures the relationship between implementation of a prior authorization process for the implantation of ventricular assist devices (VADs) and patient outcomes related to survival and readmission rates. Methods: The study population consisted of patients drawn from a national health plan claims database who either received or requested a VAD implant. The ‘pre-prior authorization’ group included patients who received an

1. Patients who received a VAD implant in the pre-prior authorization period versus patients receiving a VAD implant after prior authorization was in place. 2. Patients approved for VAD and who received the VAD versus patients who were denied or withdrew their case. Patient survival was evaluated using the Kaplan-Meier method and readmission rates were evaluated using a Chi-Square test. Results: Patients who received a VAD implant following prior authorization had significantly (p <  0.0001) higher survival rates and significantly (p <  0.0001) lower post-implant 90 day readmission rates than did patients who received a VAD implant without case review, suggesting the VAD prior authorization process may have helped avoid implanting devices in inappropriate candidates and was associated with better patient outcomes. As compared to patients who were approved to receive a VAD implant, patients whose cases were withdrawn or denied following review had significantly (p <  0.0001) higher survival rates, which provides evidence that avoidance of a VAD in these patients did not place them at increased risk. Conclusion: We conclude that the implementation of prior authorization using criteria derived from CMS and ISHLT resulted in a significant improvement in clinical outcomes for patients receiving a VAD without adversely impacting the outcomes of patients where a VAD was considered but not implanted. 1( 008) Decoupling Between Diastolic Pulmonary Artery Pressure and Pulmonary Capillary Wedge Pressure Is the Strongest Negative Prognostic Factor Post Continuous Flow Ventricular Assist Device Implantation T. Imamura ,1 G. Sayer,1 S. Adatya,1 N. Sarswat,1 G. Kim,1 J. Raikhelkar,1 T. Ota,1 T. Song,1 C. Juricek,1 V. Kagan,1 D. Rodgers,1 V. Jeevanandam,1 D. Burkhoff,2 M. Mehra,3 N. Uriel.1  1University of Chicago, Chicago, IL; 2University of Columbia, New York, NY; 3Brigham and Women's Hospital, Boston, MA. Purpose: CF-LVAD reduces pulmonary capillary wedge pressure (PCWP) via direct unloading of the left ventricle while simultaneously reducing pulmonary arterial pressure (PAP). We clinically observed that some CFLVAD patients developed "decoupling" between diastolic PAP and PCWP. This study aimed to assess the clinical implications of decoupling and to determine which patients will develop this phenomenon. Methods: In this prospective study, patients routinely underwent invasive hemodynamic study following CF-LVAD implantation. Patietns were followed for at least 1 year thereafter. Right heart catheterization (RHC) includes CVP, RVP, PAP, PCWP, Fick CO/CI and corresponding PVR, SVR and PAPi measurements. Decoupling was defined as a greater than 5 mmHg difference between diastolic PAP and PCWP. Survival and heart failure readmission rates between the groups were assessed. Results: 63 CF-LVAD patients (60±12 years old and 26 males [41%], 44 HeartMate II and 19 HVAD) underwent RHC for routine evaluation. Decoupling was observed in 27 patients (43%). Patients with decoupling were younger (56±11 vs. 63±12 years old) and had a higher rate of non-ischemic etiology (74% vs. 36%, p< 0.05 for both) compared with the non-decoupling group. Kaplan-Meier analyses revealed significant and meaningful differences in both survival (Figure A; 93% vs. 63%, p= 0.012) and freedom from heart failure readmission (Figure B; 88% vs. 54%, p= 0.043) between patients with and without decoupling. Univariate Cox Hazard Ratio analyses demonstrated that decoupling > 5 mmHg had the highest hazard ratio (HR) among all background variables for each endpoint of all-cause mortality (HR 4.142), heart failure readmission (HR 2.546), and combination of both (HR 3.523) during the 1 year study period (p< 0.05 for all).